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## Complete Summary

#### GUIDELINE TITLE

Follow-up imaging of bladder carcinoma.

#### BIBLIOGRAPHIC SOURCE(S)

Jafri SZ, Dinan D, Francis IR, Baumgarten DA, Bluth EI, Bush WH JR,
Casalino DD, Curry NS, Israel GM, Kawashima A, Papanicolaou N, Remer EM,
Sandler CM, Spring DB, Fulgham P, Expert Panel on Urologic Imaging.
Follow-up imaging of bladder carcinoma. \[online publication\]. Reston
(VA): American College of Radiology (ACR); 2007. 9 p. \[71 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Segal AJ, Choyke PL, Bluth
EI, Bush WH Jr, Casalino DD, Francis IR, Jafri SZ, Kawashima A, Kronthal
A, Older RA, Papanicolaou N, Ramchandani P, Rosenfield AT, Sandler CM,
Tempany C, Resnick MI, Expert Panel on Urologic Imaging. Follow-up
imaging of bladder carcinoma. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2005. 9 p. \[54 references\]

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Bladder cancer

#### GUIDELINE CATEGORY

Evaluation\
Risk Assessment

#### CLINICAL SPECIALTY

Nephrology\
Oncology\
Radiation Oncology\
Radiology\
Surgery\
Urology

#### INTENDED USERS

Health Plans\
Hospitals\
Managed Care Organizations\
Physicians\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of follow-up radiologic examinations for
patients with bladder cancer

#### TARGET POPULATION

Patients with bladder cancer

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  X-ray

    -   Intravenous urography

    -   Chest

    -   Abdomen, loopogram

2.  Computed tomography (CT)

    -   Urography

    -   Chest

    -   Abdomen and pelvis, with contrast

3.  Ultrasound (US), bladder

    -   Transabdominal

    -   Transurethral

    -   Transrectal

4.  Magnetic resonance imaging (MRI), abdomen and pelvis

5.  Fluorodeoxyglucose positron emission tomography (FDG-PET), whole
    body

#### MAJOR OUTCOMES CONSIDERED

Utility of radiologic examinations in the follow-up of patients with
bladder carcinoma

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The guideline developer performed literature searches of peer-reviewed
medical journals, and the major applicable articles were identified and
collected.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Not Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not stated

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

One or two topic leaders within a panel assume the responsibility of
developing an evidence table for each clinical condition, based on
analysis of the current literature. These tables serve as a basis for
developing a narrative specific to each clinical condition.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Delphi)

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Since data available from existing scientific studies are usually
insufficient for meta-analysis, broad-based consensus techniques are
needed for reaching agreement in the formulation of the appropriateness
criteria. The American College of Radiology (ACR) Appropriateness
Criteria panels use a modified Delphi technique to arrive at consensus.
Serial surveys are conducted by distributing questionnaires to
consolidate expert opinions within each panel. These questionnaires are
distributed to the participants along with the evidence table and
narrative as developed by the topic leader(s). Questionnaires are
completed by the participants in their own professional setting without
influence of the other members. Voting is conducted using a scoring
system from 1 to 9, indicating the least to the most appropriate imaging
examination or therapeutic procedure. The survey results are collected,
tabulated in anonymous fashion, and redistributed after each round. A
maximum of three rounds is conducted and opinions are unified to the
highest degree possible. Eighty percent agreement is considered a
consensus. This modified Delphi technique enables individual, unbiased
expression, is economical, easy to understand, and relatively simple to
conduct.

If consensus cannot be reached by this Delphi technique, the panel is
convened and group consensus techniques are utilized. The strengths and
weaknesses of each test or procedure are discussed and consensus reached
whenever possible. If \"No consensus\" appears in the rating column,
reasons for this decision are added to the comment sections.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Criteria developed by the Expert Panels are reviewed by the American
College of Radiology (ACR) Committee on Appropriateness Criteria.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**ACR Appropriateness Criteria®**

**Clinical Condition: Follow-up Imaging of Bladder Carcinoma**

**Variant 1: Superficial TCC - no invasion or risk factors.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  CT urography          3                                              Med

  X-ray intravenous     3            Utilization of intravenous        Low
  urography                          urography has continued to        
                                     decline with the increasing       
                                     widespread use of CT urography.   

  X-ray chest           2                                              Min

  FDG-PET whole body    1                                              High

  US bladder            1                                              None
  transabdominal                                                       

  MRI abdomen and       1                                              None
  pelvis                                                               

  US bladder            1                                              None
  transurethral                                                        

  US bladder            1                                              None
  transrectal                                                          

  CT chest              1                                              Med

  CT abdomen and pelvis 1                                              High

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 2: Invasive TCC with or without cystectomy.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  X-ray chest           9                                              Min

  CT urography          8                                              Med

  X-ray abdomen         8            In patients with an ideal loop    Low
  loopogram                          post cystectomy.                  

  X-ray intravenous     5            Utilization of intravenous        Low
  urography                          urography has continued to        
                                     decline with the increasingly     
                                     widespread use of CT urography.   

  MRI abdomen and       5            See comments regarding contrast   None
  pelvis                             in text under \"Anticipated       
                                     Expectations.\"                   

  CT abdomen and pelvis 5            Appropriate if MDCT urography is  High
  with contrast                      not available. Visceral/nodal     
                                     status evaluated during CT        
                                     urography.                        

  CT chest              3            Performed if chest x-ray is       Med
                                     equivocal.                        

  US bladder            3                                              None
  transabdominal                                                       

  FDG-PET whole body    2            Indicated for suspected nodal or  High
                                     distant metastasis.               

  US bladder            2                                              None
  transrectal                                                          

  US bladder            2                                              None
  transurethral                                                        

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 3: Superficial TCC -- no invasion with risk factors.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  CT urography          8                                              Med

  X-ray intravenous     5            Utilization of intravenous        Low
  urography                          urography has continued to        
                                     decline with the increasingly     
                                     widespread use of CT urography.   

  X-ray chest           5                                              Min

  CT abdomen and pelvis 3            Visceral/nodal status evaluated   High
  with contrast                      during CT urography.              

  FDG-PET whole body    1                                              High

  US bladder            1                                              None
  transrectal                                                          

  CT chest              1                                              Med

  US bladder            1                                              None
  transabdominal                                                       

  US bladder            1                                              None
  transurethral                                                        

  MRI abdomen and       1                                              None
  pelvis                                                               

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Summary of Literature Review**

Transitional cell carcinoma (TCC) of the bladder accounts for 95% of all
bladder cancer in the United States. It is the second most common
genitourinary malignancy and the fifth leading cause of cancer deaths in
American males over 75 years of age. In 2006, approximately 61,420 new
cases were expected to occur. Bladder cancer occurs about four times
more commonly in men than in women and with double the frequency in
whites compared to African Americans. According to the American Cancer
Society, \"An estimated 13,060 deaths will occur in 2006. For all stages
combined, the 5-year relative survival rate is 82%. When diagnosed at a
localized stage, the 5-year survival rate is 94%; 75% of cancers are
detected at this early stage. For regional and distant stages, 5-year
relative survival rates are 48% and 6%, respectively. Beyond 5 years,
survival continues to decline, with a rate of 75% at 10 years and 70% at
15 years after diagnosis.\" Patients who have been diagnosed and treated
for TCC require follow-up evaluation, which is usually based upon the
type of treatment as well as accurate initial grading and staging of the
tumor.

The purposes of follow-up imaging evaluation are to detect new or
previously undetected tumor, to detect recurrent or metastatic disease,
and to monitor the effects and/or complications following urinary
diversion surgery. Recommendations for tumor surveillance can be based
on the classification of patients into three groups; 1) those with
superficial bladder cancer but no additional risk factors and treated by
local therapy; 2) those with superficial bladder cancer with additional
risk factors but still treated by local therapy; and 3) those with
invasive bladder cancer, usually treated with cystectomy.

In patients with newly diagnosed TCC, the median time to the first
recurrence is 31 months. Subsequent recurrences present with increasing
frequency.

The likelihood of recurrent or metastatic disease increases with the
presence of one or more of the following risk factors:

1.  **Depth of invasion** - Most TCCs of the bladder (75 to 85%) are
    superficial. Although the risk of recurrence is approximately 75%,
    most remain superficial, with only 10% to 15% progressing to
    invasive carcinoma. There is evidence to indicate that cancers that
    invade the lamina propria (stage T1) should not be regarded as
    superficial. High-grade stage T1 tumors may progress to invade
    muscle in 30% to 50% of cases. When this occurs, the prognosis is as
    poor as it is for those presenting initially with invasive cancer.
    More than 50% of patients who are treated locally for invasive
    cancer manifest distant metastases, and they usually die of their
    disease within 2 years.

2.  **Tumor size** - Various studies have shown that tumors greater than
    3 cm have up to a 35% chance of progression, and tumors greater than
    10 grams are also associated with a poor prognosis.

3.  **Grade** - Progression from grade I to III in patients without
    interval intravesical chemotherapy, cystectomy, or radiation therapy
    has been associated with an increased incidence of invasive disease
    and a decreased 5-year survival. In one study, fewer than 10% of
    grade I tumors but as many as 50% of grade II tumors and more than
    80% of grade III tumors were found to be invasive at the time of
    initial diagnosis. In another study, the 5-year survival of patients
    with grade I tumors was 94%, but only 40% for patients with grade
    III tumors.

4.  **Adjacent or remote bladder mucosal changes** - If there are
    adjacent or distant changes of atypia or dysplasia, there is a
    significant chance of progression to muscle invasion (more than 30%
    within four years of diagnosis). Carcinoma in situ (CIS), in
    patients with low-grade, low-stage lesions may be associated with
    progression to muscle invasion (greater than 80% within 4 years of
    diagnosis).

5.  **Multiplicity of foci** - The finding of multiple tumors is seen in
    approximately 30% of cases and is associated with a recurrence rate
    that is almost one-third higher than it is in patients with single
    lesions. This finding is generally associated with a shortening of
    the average time until recurrence. Two of three patients with single
    lesions but nine of ten with multiple lesions developed recurrent
    carcinoma. In a randomized clinical trial evaluating the prognostic
    factors associated with recurrence of T1 cancers, the number of
    tumors (worst for those with three or more) at the time of
    presentation was most important followed, in order of importance, by
    the number of recurrences (significantly greater chance of future
    recurrence for those patients with more than one recurrence per
    year) and the size of the largest tumor (worst for those over 3 cm).

6.  **Upper tract obstruction** has been associated with a decreased
    5-year survival rate. Patients with bilateral hydronephrosis had a
    5-year survival of 31%, compared with 45% for those who had
    unilateral involvement and 63% for those with no hydronephrosis.

7.  **Lymphatic invasion** in the lamina propria is a very poor
    prognostic sign, and most patients so affected die within 6 years.
    Solid (nonpapillary) lesions have a greater tendency for lymphatic
    invasion.

8.  **TCC involvement of the prostate** - When TCC of the bladder is
    associated with involvement of the prostate (and it has been
    observed in 29% to 43% of cystectomy specimens), particularly with
    stromal invasion, there is a substantially increased risk of
    urethral recurrence. Sixty-seven percent of men with urethral
    recurrence had prostatic TCC in cystectomy specimens. Urethral
    recurrence can be expected in only 1% to 4% of cases when there is
    no TCC in the prostate. Those patients who are not candidates for
    cystoprostatectomy with urethrectomy are best followed up with
    urethral washings. Urethroscopy is performed in those having
    positive cytologic results.

9.  **Laboratory tests and chromosomal abnormalities** - A number of
    laboratory tests have been used to prognosticate tumor progression.
    These include tests for Thompson-Friedenreich (T) antigen
    expression, lectin-binding carbohydrate structures, ABH blood group
    antigens, oncofetal protein expression, and epidermal growth factor
    receptors. According to one study, \"these tests have not been
    adopted into clinical practice to influence treatment decisions in
    individual patients.\" Chromosomal abnormalities in tumors (marker
    chromosomes and a large proportion of aneuploid tumor cell lines)
    have also been used to predict tumor recurrence or progression.

**Cystoscopic and Virtual Cystoscopic Surveillance**

Recommended surveillance for patients treated for superficial bladder
TCC includes cystoscopy every 3 months for 2 years, then every 6 months
for 2 years, and then yearly thereafter. There has been interest in
developing virtual cystoscopic or cystographic techniques using magnetic
resonance imaging (MRI) and computed tomography (CT) both for problem
solving in cases that are suboptimal for standard cystoscopy
(narrow-necked diverticula) and as a way to avoid the patient discomfort
associated with standard cystoscopy. One study demonstrated CT
cystography to have a 100% sensitivity in identifying 0.5 cm masses and
a sensitivity of 95% for all patients in detecting neoplasm with an
accuracy of 88%. Another study examined MR cystography (multiplanar
reconstructions) and cystoscopy demonstrating a combined sensitivity and
specificity of 90.7% and 94.0% respectively. Multiplanar MR
reconstructions (cystography) alone demonstrated sensitivity of 92.3%
and specificity of 91.1% and MR cystoscopy demonstrated sensitivity of
90.7% and specificity of 90.4%. Both CT and MR cystoscopy provide views
comparable to standard cystoscopy.

Urinalysis and cytologic evaluation should be performed at the time of
each cystoscopy. Positive cytologic findings are followed by examination
of the remaining bladder or upper tracts. There has been interest in
developing quantitative tests to complement or even replace urinary
cytology in follow-up of bladder carcinoma. One study demonstrated 85%
sensitivity in detecting recurrent bladder cancer using the NMP22 marker
detection device versus 41% sensitivity for traditional cytology,
suggesting that it may substitute for urinary cytology. Additional
studies demonstrate similar sensitivities for detecting bladder cancer
with various molecular markers and some of these studies suggest that,
due to its sensitivity, immunohistochemical testing may increase the
time period between cystoscopies or even replace cystoscopy.

Intravenous pyelography (IVP) was once the most common imaging modality
used to evaluate the urothelium of the upper collecting system. CT
urography has begun to supplant IVP as its use becomes increasingly
widespread. Although some suggest an upper urinary tract imaging study
such as these every one or two years, most believe that, in the absence
of risk factors, urine cytologic evaluation and cystoscopy are
sufficiently accurate, especially since the risk of upper-tract TCC in
all patients treated for bladder carcinoma is only about 2%--5% and the
mean interval between initial treatment of bladder tumor and detection
of subsequent upper-tract cancer is 70-80 months. This low risk may not
be sufficient to justify routine upper-tract screening, in spite of the
fact that not all recurrences give positive cytologic results or are
associated with hematuria.

In a study limited to patients who had their initial bladder cancer
treated with radical cystectomy only, the mean interval between
cystectomy and detection of upper tract tumors was approximately 40
months (range 8-100). Surveillance of the upper tracts is appropriate in
patients with positive urine cytologic results or every one to two years
in patients with the following risk factors (usually post-cystectomy):

1.  **Carcinoma in situ (CIS)** - When found in the cystectomy specimen,
    patients had a 9% to 13% incidence of upper tract TCC, with a
    correlation between the extent of the CIS and the risk of upper
    tract TCC.

2.  **Urethral CIS** - When present, the likelihood of upper tract TCC
    increases to 20 to 30%.

3.  **Multiple tumors**.

4.  **Recurrent tumors**.

5.  **Tumors involving the ureteral orifices**.

6.  **Tumors arising in bladder diverticula** as a result of later
    detection and earlier transmural tumor extension.

If a documented recurrence is invasive, the patient is then staged.

If CT urography cannot be done if there is incomplete visualization or
nonvisualization of the collecting structures, evaluation can be
supplemented with retrograde pyelography or, in those patients with
ileal conduits, replaced by loopogram. CT urography is also promising in
those patients with urinary diversions and may provide additional
diagnostic information as it provides examination of the entire abdomen
and pelvis unlike a standard loopogram. A preliminary study demonstrated
that CT urography with 3D rendering depicted both normal and abnormal
postoperative findings in patients with urinary diversions. The addition
of digital radiography enhanced visualization of the urinary collecting
system to a statistically significant degree. Antegrade pyelography is
uncommon but occasionally performed for diagnosis when the above
techniques fail or if the collecting system is directly accessed to
perform urine cytology or nephroscopy.

Modern imaging techniques have led to more accurate tumor staging and
detection of recurrences. These results in stage migration as patient
with \"\...silent or early metastases, \[move\] from lower into
higher\...\" TNM (tumor, nodes, metastases) categories. When CT is used
to evaluate patients following cystectomy, the pelvis is the most common
site of recurrence. In these cases, the CT should include evaluation of
the abdomen and perineum so that unsuspected, isolated abdominal
metastases and recurrent perineal tumor will not be missed. Most
metastases are detected within the first 18 to 24 months following
surgery. Bladder cancer deaths occur within 2 years of the initial
diagnosis in over 80% of cases. The most common sites of metastatic TCC
are lymph nodes, liver, lung, bone, and adrenal glands.

**Computed Tomography**

CT is recommended at 6, 12, and 24 months for follow-up of patients with
minimal muscle invasion (T2) who either elect cystectomy or other types
of therapy without cystectomy, since most recurrences become evident
within the first 2 years after surgery. There is a different
recommendation for follow-up of patients treated with a
bladder-preserving surgery. In these patients with transurethral
resection of localized muscle-invasive TCC and follow-up combined
neoadjuvant chemotherapy and radiation therapy, CT scans of the abdomen
and pelvis are performed at 3 months after completion of radiation
therapy and then every 6 months or \"as otherwise indicated.\"

**Magnetic Resonance Imaging**

MRI of the bladder may be used to evaluate of superficial bladder
tumors. CT provides limited visualization of the depth of tumor invasion
within the bladder wall. MRI, even without intravenous contrast
enhancement, has been noted to be \"superior to clinical staging\" and
to allow distinction between advanced T3a tumors and the less invasive
T1, T2, and early T3a lesions. One study demonstrated staging accuracies
of 85% and 82% in differentiating superficial from muscle-invasive
tumors and organ-confined from non-organ-confined tumors, respectively.
Additionally, the accuracy of pathologic lymph node detection was 96%.
Overstaging occurred in 32% of cases. Another study reviewed 71 patients
using gadolinium-enhanced endorectal surface coil and reported an 83%
overall staging accuracy. Muscle invasion was diagnosed with 87%
accuracy, 91% sensitivity, and 87% specificity.

Although more costly than CT, MRI is more accurate in differentiating
between T3b and T4a, between T4a and T4b, and between marrow and no
marrow infiltration. MRI performed with ferumoxtran-10 (ultrasmall
superparamagnetic iron oxide) contrast demonstrated accuracies in
pathologic lymph node detection of up to 92% and sensitivities of up to
96%. These improved techniques for detecting new, recurrent, or
metastatic tumors in patients with proven invasive TCC have sometimes
been associated with decreased morbidity, although not with increased
curability.

**Ultrasonography**

Abdominal and transurethral ultrasonography (US) have had \"limited
success\" in the evaluation of bladder cancer for determining its local
extent. Transabdominal US has \"important limitations,\" particularly
for tumors that are flat, smaller than 5 mm, or near the bladder neck
and when there has been both understaging and overstaging. However,
using transrectal US (TRUS), it is possible to detect almost all lesions
in the region of the bladder neck and dome, as well as a number of small
tumors (\<5 mm). Some evidence suggests that there is improved bladder
tumor staging when TRUS is used in conjunction with MRI. TRUS has also
been effective for monitoring tumor response or recurrence following
neoadjuvant chemotherapy.

**Chest Radiography**

Chest radiography (PA and lateral) to search for occult metastases
should be obtained at 6, 12, 18, and 24 months and then yearly for up to
5 years following cystectomy. A lung lesion suspected on chest
radiography may be appropriately followed by a CT scan of the chest for
improved definition.

**Positron Emission Tomography**

Currently, there is a limited role for positron emission tomography
(PET) imaging in the assessment of bladder cancer. According to one
study, \"It has a high positive predictive value and can be used for
problem solving in patients with indeterminate findings on conventional
imaging.\" Another study used PET in 12 patients with histologically
proven bladder cancer. \"The study demonstrated a true-positive rate of
66.7% and a false-negative rate of 33.3%. PET was able to identify 100%
(17/17) of distant metastases (lung, bone, and remote lymph node) as
well as 66.7% (2/3) of local pelvic lymph nodes.\" Therefore,
\"fluorine-18 fluorodeoxyglucose (FDG-PET) might be useful in detecting
perivesical tumor growth or distant metastasis in patients with advanced
bladder cancer, and for the early detection of recurrent cancer
following therapy, although a major remaining pitfall is the intense FDG
accumulation due to excretion in the urine.\"

Likewise, a review of PET imaging in patients with bladder, prostate,
and renal cancer concluded that ^18^F-FDG is unsuitable for imaging
bladder tumors because of its high urinary excretion, although there may
be a role in detection of recurrent disease. A study correlating
^18^F-FDG-PET and CT results in the same patients reported sensitivity,
specificity, and accuracy of 60%, 88%, and 78%, respectively, in nodal
and metastasis staging, suggesting improved distant metastatic and
locoregional node staging. Preliminary studies show that ^11^C-choline
PET when compared with CT promises slightly increased accuracy of lymph
node staging (63.0% vs 88.9%, *p* \<0.01) and may avoid false-positive
lymph nodes due to reactivity when compared with CT. In addition there
is negligible urinary excretion of ^11^C-choline.

**Summary**

Routine imaging follow-up is **NOT** indicated for patients with
superficial TCC and no invasion of the lamina propria or additional risk
factors. Patients with superficial TCC require careful observation and
IVP or CT urography every 1-2 years **IF** any of the following risk
factors for recurrent tumor are present:

1.  Tumor size greater than 3 cm or 10 grams

2.  Higher than grade I tumor, or

3.  Adjacent or remote bladder mucosal changes or dysplasia or CIS.
    Additional imaging may be necessary if there are positive urine
    cytologic findings, hematuria, or abnormal cystoscopy.

Patients with invasive TCC, especially those with evidence of: 1)
lymphatic or 2) hematogenous invasion, those with associated 3)
dysplasia or 4) CIS in the cystectomy specimen, those with associated 5)
urethral TCC, 6) multifocal bladder tumors, 7) recurrent bladder tumors,
and 8) tumors in bladder diverticula or 9) involving the ureterovesical
junctions\--should have an IVP or CT urography every 1-2 years. If IVP
is inadequate or not possible, CT urography, loopogram, or pyelography
(retrograde or antegrade) can be used as a substitute or supplement.
Patients requiring cystectomy for invasive bladder cancer should have an
MRI or a CT scan at 6, 12, and 24 months and a chest x-ray at 6, 12, 18,
24, 36, 48, and 60 months postoperatively. If recurrent bladder cancer
is found and considered invasive, new staging may be required (see the
NGC summary of the ACR Appropriateness Criteria® topic [Pretreatment
Staging of Invasive Bladder
Cancer](http://www.guideline.gov/summary/summary.aspx?doc_id=11581&nbr=005999)).

**Anticipated Exceptions**

Patients treated with bladder-preserving surgery and follow-up
neoadjuvant chemotherapy and/or radiation therapy for localized
muscle-invasive TCC may require more frequent CT and/or MRI. TRUS may be
used in selected cases when it is considered helpful. PET imaging may be
helpful in cases of advanced bladder cancer, particularly for detection
of regional lymph node spread or distant metastases.

Nephrogenic systemic fibrosis (NSF, also known as nephrogenic fibrosing
dermopathy) was first identified in 1997 and has recently generated
substantial concern among radiologists, referring doctors and lay
people. Until the last few years, gadolinium-based MR contrast agents
were widely believed to be almost universally well tolerated, extremely
safe and non-nephrotoxic, even when used in patients with impaired renal
function. All available experience suggests that these agents remain
generally very safe, but recently some patients with renal failure who
have been exposed to gadolinium contrast agents (the percentage is
unclear) have developed NSF, a syndrome that can be fatal. Further
studies are necessary to determine what the exact relationships are
between gadolinium-containing contrast agents, their specific components
and stoichiometry, patient renal function and NSF. Current theory links
the development of NSF to the administration of relatively high doses
(e.g., \>0.2 mM/kg) and to agents in which the gadolinium is least
strongly chelated. The FDA has recently issued a \"black box\" warning
concerning these contrast agents
(<http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705HCP.pdf>).

This warning recommends that, until further information is available,
gadolinium contrast agents should not be administered to patients with
either acute or significant chronic kidney disease (estimated GFR \<30
mL/min/1.73m^2^), recent liver or kidney transplant or hepato-renal
syndrome, unless a risk-benefit assessment suggests that the benefit of
administration in the particular patient clearly outweighs the potential
risk(s).

**Abbreviations**

-   CT, computed tomography

-   FDG PET, fluorodeoxyglucose positron emission tomography

-   Med, medium

-   Min, minimal

-   MRI, magnetic resonance imaging

-   TCC, transitional cell carcinoma

-   US, ultrasound

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are based on analysis of the current literature and
expert panel consensus.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Selection of appropriate radiologic imaging procedures for evaluation of
patients with bladder cancer

#### POTENTIAL HARMS

-   The relative radiation level is high for computed tomography (CT) of
    the abdomen and pelvis and whole body fluorodeoxyglucose positron
    emission tomography (FDG-PET). CT urography and CT of the chest have
    a medium relative radiation level.

-   Some patients with renal failure who have been exposed to gadolinium
    contrast agents (the percentage is unclear) have developed
    nephrogenic systemic fibrosis, a syndrome that can be fatal.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

An American College of Radiology (ACR) Committee on Appropriateness
Criteria and its expert panels have developed criteria for determining
appropriate imaging examinations for diagnosis and treatment of
specified medical condition(s). These criteria are intended to guide
radiologist, radiation oncologist, and referring physicians in making
decisions regarding radiologic imaging and treatment. Generally, the
complexity and severity of a patient\'s clinical condition should
dictate the selection of appropriate imaging procedures or treatments.
Only those exams generally used for evaluation of the patient\'s
condition are ranked. Other imaging studies necessary to evaluate other
co-existent diseases or other medical consequences of this condition are
not considered in this document. The availability of equipment or
personnel may influence the selection of appropriate imaging procedures
or treatments. Imaging techniques classified as investigational by the
U.S. Food and Drug Administration (FDA) have not been considered in
developing these criteria; however, study of new equipment and
applications should be encouraged. The ultimate decision regarding the
appropriateness of any specific radiologic examination or treatment must
be made by the referring physician and radiologist in light of all the
circumstances presented in an individual examination.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Jafri SZ, Dinan D, Francis IR, Baumgarten DA, Bluth EI, Bush WH JR,
Casalino DD, Curry NS, Israel GM, Kawashima A, Papanicolaou N, Remer EM,
Sandler CM, Spring DB, Fulgham P, Expert Panel on Urologic Imaging.
Follow-up imaging of bladder carcinoma. \[online publication\]. Reston
(VA): American College of Radiology (ACR); 2007. 9 p. \[71 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1996 (revised 2007)

#### GUIDELINE DEVELOPER(S)

American College of Radiology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American College of Radiology (ACR) provided the funding and the
resources for these ACR Appropriateness Criteria®.

#### GUIDELINE COMMITTEE

Committee on Appropriateness Criteria, Expert Panel on Urologic Imaging

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: S. Zafar H. Jafri, MD (*principal author*); David
Dinan, MD; Isaac R. Francis, MD; Deborah A. Baumgarten, MD; Edward I.
Bluth, MD; William H. Bush, Jr., MDE; David D. Casalino, MD; Nancy S.
Curry, MD; Gary M. Israel, MD; Akira Kawashima, MD; Nicholas
Papanicolaou, MD; Erick M. Remer, MD; Carl M. Sandler, MD; David B.
Spring, MD; Pat Fulgham, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Segal AJ, Choyke PL, Bluth
EI, Bush WH Jr, Casalino DD, Francis IR, Jafri SZ, Kawashima A, Kronthal
A, Older RA, Papanicolaou N, Ramchandani P, Rosenfield AT, Sandler CM,
Tempany C, Resnick MI, Expert Panel on Urologic Imaging. Follow-up
imaging of bladder carcinoma. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2005. 9 p. \[54 references\]

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American College of Radiology (ACR) Web
site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonUrologicImaging/FollowUpImagingofBladderCarcinomaDoc4.aspx).

ACR Appropriateness Criteria® *Anytime*, *Anywhere*™ (PDA application).
Available from the [ACR Web
site](http://www.acr.org/SecondaryMainMenuCategories/ACRStore/FeaturedCategories/QualityandSafety/ac_pda.aspx).

Print copies: Available from the American College of Radiology, 1891
Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   ACR Appropriateness Criteria®. Background and development. Reston
    (VA): American College of Radiology; 2 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [American
    College of Radiology (ACR) Web
    site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria.aspx).

-   ACR Appropriateness Criteria®. Relative radiation level information.
    Reston (VA): American College of Radiology; 2 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [American
    College of Radiology (ACR) Web
    site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/RRLInformation.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on March 6, 2006. This NGC
summary was updated by ECRI Institute on November 15, 2007.

#### COPYRIGHT STATEMENT

Instructions for downloading, use, and reproduction of the American
College of Radiology (ACR) Appropriateness Criteria® may be found on the
[ACR Web
site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/ACRAppropriatenessCriteriaTermsandConditionsDoc1.aspx).

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
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Guidelines represented on the NGC Web site are submitted by guideline
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Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/10/2008