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## Complete Summary

#### GUIDELINE TITLE

Staging of bronchogenic carcinoma.

#### BIBLIOGRAPHIC SOURCE(S)

Rozenshtein A, Davis SD, Ritsuko RU, Bradley JD, Gopal RS, Haramati LB,
McLoud TC, Movas B, Rosenzweig KE, White CS, Kaiser LK, Schiller JH,
Expert Panel on Thoracic Imaging and Radiation, Oncology-Lung Work
Group. Staging of bronchogenic carcinoma. \[online publication\]. Reston
(VA): American College of Radiology (ACR); 2005. 9 p. \[42 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This updates two previously published versions: McLoud TC, Westcott J,
Davis SD, Fleishon H, Gefter WB, Henschke CI, Pugatch RD, Sostman HD,
Tocino I, White CS, Yankelevitz D, Bode FR. Staging of bronchogenic
carcinoma, non-small cell lung carcinoma. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215 (Suppl):611-9 and
Ko B, Sause WT, Byhardt RW, Curran WJ, Fuller D, Graham MV, Komaki R,
Weisenburger TH, Kaiser LR, Leibel SA, Brown RC. Staging of non-small
cell lung carcinoma. American College of Radiology. ACR Appropriateness
Criteria. Radiology 2000 Jun;215(Suppl):1281-94.

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)

Bronchogenic carcinoma, non-small cell and small cell lung carcinoma

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation

#### CLINICAL SPECIALTY

Internal Medicine\
Nuclear Medicine\
Oncology\
Pulmonary Medicine\
Radiology

#### INTENDED USERS

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

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of initial radiologic examinations for
patients with bronchogenic carcinoma, non-small cell and small cell lung
carcinoma

#### TARGET POPULATION

Patients with bronchogenic carcinoma, non-small cell and small cell lung
carcinoma

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  X-ray

    -   Posterior-anterior (PA), chest

    -   Lateral

2.  Computed tomography (CT)

    -   Thorax (including adrenal glands)

    -   Abdomen

    -   Brain

3.  Magnetic resonance imaging (MRI)

    -   Brain

    -   Thorax

4.  Fluorodeoxyglucose-positron emission tomography (FDG-PET)

5.  Nuclear medicine (NUC), bone scintigraphy

#### MAJOR OUTCOMES CONSIDERED

Utility of radiologic examinations in staging of bronchogenic 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

The total number of source documents identified as the result of the
literature search is not known.

#### 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: Staging of Bronchogenic Carcinoma**

**Variant 1: Non-Small Cell Lung Carcinoma**

  ---------------------------------------------------------------------------
  **Radiologic Exam    **Appropriateness   **Comments**
  Procedure**          Rating**            
  -------------------- ------------------- ----------------------------------
  CT, thorax           9                    
  (including adrenal                       
  glands)                                  

  X-ray, chest, PA and 8                    
  lateral                                  

  FDG PET              8                    

  MRI, brain           7                   Particularly if neuro symptoms are
                                           present

  CT, abdomen          5                    

  CT, brain            5                   If MRI contraindicated and neuro
                                           symptoms are present

  NUC, bone            5                   Not necessary if PET has been
  scintigraphy                             done.

  MRI, thorax          3                   Useful for evaluating chest wall
                                           invasion and for local staging of
                                           superior sulcus tumors.

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

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

**Variant 2: Small Cell Lung Carcinoma**

  ---------------------------------------------------------------------------
  **Radiologic Exam    **Appropriateness   **Comments**
  Procedure**          Rating**            
  -------------------- ------------------- ----------------------------------
  X-ray, chest, PA and 9                    
  lateral                                  

  CT, thorax           9                    
  (including adrenal                       
  glands)                                  

  MRI, brain           8                    

  FDG PET              7                    

  CT, abdomen          5                    

  CT, brain            5                   If MRI contraindicated and neuron
                                           symptoms are present

  NUC, bone            5                   Not necessary if PET has been
  scintigraphy                             done.

  MRI, thorax          2                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

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

**Non-Small Cell Lung Carcinoma**

**Staging**

Staging of any tumor is done to determine the extent of disease. Staging
information is important for two reasons: 1) to determine prognosis and
2) to select patients for surgical intervention and/or a different
modality. The TNM system is widely used to classify lung tumors. In
1986, the staging system was revised on the basis of epidemiologic
evidence of improved survival after surgical resection in patients who
had previously been classified as having unresectable disease. In the
TNM classification, \"T\" indicates the features of the primary tumor,
\"N\" indicates metastasis to regional lymph nodes, and \"M\" refers to
the presence or absence of distant metastases (Tables 1 and 2 of the
original guideline document). In the old (pre 1985) lung cancer
classification, stage I and II tumors were considered amenable to
surgical management, and stage III tumors were considered unresectable.
The revised 1985 system and the current Mountain classification consist
of four stages: stage IV includes only those patients with evidence of
distant metastasis (M1). Stage III has been redefined and divided into
stages IIIa and IIIb. Of these two categories, stage IIIb is also
considered unresectable disease. In the previous classification, tumors
with limited invasion of the chest wall and mediastinum were included in
this inoperable category, but under the new classification, such tumors
are considered to be potentially resectable provided that vital
structures in the mediastinum, such as the great vessels, heart, and
aerodigestive tract, are not involved. The designation T4 is now used to
describe lesions with extensive invasion of the mediastinum or
diaphragm. In addition in the current system, patients with ipsilateral
nodal metastasis are also considered to have resectable cancer. However,
for the most part, only patients with limited ipsilateral mediastinal
nodal disease fall into the operable category. These are usually cases
in which the tumor is contained within the capsule of the lymph nodes
and is limited to involvement of the lower mediastinal nodes. The
category N3 was added to the TNM staging to refer to contralateral
mediastinal or hilar lymph node or supraclavicular lymph node
metastasis. N3 disease is considered to be in the nonsurgical or
unresectable category.

In 1997, further revisions were introduced into the staging grouping of
the TNM subsets in the International System for Staging Lung Cancer.
This was adopted by the American Joint Committee on Cancer and the Union
Internationale Contre le Cancer. The changes from the previous
classification are minor. Stage I has been divided into two groups: IA
and IB. T4 has also been slightly redefined to include satellite tumor
nodule(s) within the ipsilateral primary lobe of the lung. Previously,
any additional nodules had been considered evidence of distant
metastatic disease (M1). The definitions of stages IIA, IIB, IIIA, and
IIIB are included in Table 2 of the original guideline document. In
regard to stage I, data have consistently shown a better outcome for
patients with T1N0M0 lung tumors than for any other subsets. Survival is
estimated to be approximately 60% in patients with clinical stage IA
disease and only 38% for those in clinical stage IB. Stage IB is
designated as patients with T2 tumors. Regarding stage II, the survival
rate for patients with T1N1M0 disease, that is, T1 lesions with involved
hilar nodes, is higher than for those with T2N1M0 disease. However, the
former is a small group of patients, who are encountered rather
infrequently. Definitions for stage IIIA and IIIB are provided in Table
2 of the original guideline document.

A number of imaging modalities have historically been used in staging
lung cancer. These have included standard and conventional tomography as
well as CT and MRI. In some instances, accurate staging and the
determination of appropriate treatment for patients with lung cancer can
be made noninvasively with imaging modalities alone, although in most
cases, some degree of surgical staging and biopsy evidence is also
necessary.

**Chest Radiographs - PA and Lateral**

The need for appropriateness guidelines for routine chest radiographs in
lung cancer appears to be a non-issue. The vast majority of primary lung
cancers are initially detected on routine chest radiographs. There may
be certain instances in which the chest radiograph alone is a sufficient
imaging procedure for staging - for example, when an obvious metastatic
bone lesion is detected or when large bulky contralateral mediastinal
lymph nodes are present. However, numerous studies have shown that the
chest radiograph lacks sensitivity in detecting mediastinal lymph node
metastases and in detecting chest wall and mediastinal invasion.

**Computed Tomography**

CT has now become the major imaging modality of choice in the evaluation
of patients with bronchogenic carcinoma. Numerous studies have shown
that the value of CT in staging is limited, because there are no
morphologic criteria that would allow distinction between benign and
malignant lymph nodes. It is certainly more sensitive than standard
radiography, however, and it may serve as a guide to surgical management
and in the determination of appropriate methods for surgical staging.

Traditionally, chest CT for staging of lung cancer is extended into the
abdomen to include the adrenal glands. Whether this requires intravenous
contrast material is debatable. The recent work of one study addressed
the question of whether administration of intravenous contrast material
at CT of the thorax and upper abdomen (including the liver) changed the
tumor stage and management compared with nonenhanced helical CT in 96
patients with newly diagnosed lung cancer. Although four of these
patients were either upstaged or downstaged after intravenous contrast
administration, there was no change in management. The authors concluded
that contrast-enhanced CT extended to include the liver rarely adds to
routine nonenhanced CT through the adrenal glands and does not influence
management decisions.

**Evaluation of Primary Tumor (the T Factor)**

It is not always possible to distinguish T3 from T4 lesions with imaging
studies. Lesions with chest wall invasion are classified as T3 lesions
and are potentially resectable. Surgical resection, however, requires an
en bloc resection of the pulmonary malignancy and the contiguous chest
wall and is associated with an operative mortality in the range of 8 to
15%. It is usually desirable, therefore, to determine preoperatively if
chest wall invasion is present in order to select patients as operative
candidates. Although CT certainly provides information incrementally
superior to that of radiographs, many of the findings described in the
literature that are said to be associated with chest wall invasion have
been shown to be neither sensitive nor specific. One study demonstrated
a sensitivity of only 62% for CT in distinguishing T3 to T4 tumors from
T0 to T2 tumors. Similarly, another study found CT to be of limited
value assessing chest wall invasion, with a sensitivity of 87% and
specificity of only 59%. CT was found to be more specific in assessing
chest pain (94%). Some of the signs that have been described include
pleural thickening adjacent to the tumor, encroachment on or increased
density of subpleural fat, or an obtuse angle between the pulmonary mass
and the pleural surface. Only the presence of a mass in the chest wall
or definite rib destruction are helpful indicators of chest wall
invasion.

Similarly, CT may be useful when extensive mediastinal invasion is
present. Contrast-enhanced images may show vascular encasement and
involvement of major mediastinal organs. However, CT is unable in some
instances to distinguish contiguity of tumor with the mediastinum from
actual invasion of the walls of vital mediastinal structures. In one
study the sensitivity of CT depended on the sign of mediastinal invasion
that was used. It was only 40% for 90 degrees of contact between the
mass and the mediastinal structure, and 44% if distortion of the
mediastinal structure was present. Positive predictive values were low,
and these authors concluded that CT was not useful in determining
mediastinal invasion. Another study used pneumothorax combined with CT
to determine the presence of chest wall and mediastinal invasion by lung
cancer. Although the sensitivity and specificity are both high, the
study included only a small number of cases, and the technique is
invasive.

**Evaluation of Nodal Metastasis (the N Factor)**

CT has become the method of choice for assessing mediastinal nodes in
bronchogenic carcinoma. Previously, patients with mediastinal nodal
metastasis from bronchogenic carcinoma were not considered to benefit
from surgery. However, numerous studies have consistently documented
improved survival of selected patients after resection of mediastinal
nodal disease and, in most cases, adjuvant radiation therapy. The new
American Joint Committee on Cancer Staging now considers patients with
ipsilateral mediastinal lymph node metastasis (N2) as potentially
surgically resectable stage IIIa disease. Included in this group are
patients with 1) intracapsular rather than extracapsular involvement and
2) positive nodes identified at thoracotomy after negative
mediastinoscopy. In addition, early reports have indicated that even
patients with gross and bulky ipsilateral nodal metastasis (N2) may
benefit from surgery if it is combined with neoadjuvant chemotherapy and
radiation therapy. However, patients with contralateral mediastinal
nodal involvement (N3) are considered to have unresectable stage IIIb
disease.

Several studies have addressed the accuracy of CT in the staging of
mediastinal nodal metastasis in lung cancer. More recent studies that
have used total nodal sampling and the American Thoracic Society Lymph
Node Classification have generally shown a lower sensitivity of CT in
detecting nodal metastasis. One study reported that the sensitivity and
specificity of CT were 64% and 62%, respectively. This study used 1 cm
as the upper limit of normal diameter for the short axis of lymph nodes
and also used extensive lymph node sampling that was correlated closely
with CT nodal stations. Another study used similar methodology and
showed a somewhat higher sensitivity of 79%, which approached that of
mediastinoscopy. However, they used the long axis for lymph node
measurement. They concluded that CT and mediastinoscopy were
complementary, particularly because CT often showed enlargement of lymph
nodes in groups that were inaccessible at mediastinoscopy. But another
study found that in detecting mediastinal nodal metastasis, CT had a
sensitivity of 81% with central tumors and 71% with peripheral tumors.
The negative predictive index, however, was 93%. Based on this figure,
they suggested that mediastinoscopy is not necessary when the CT scan is
negative. However, they did recommend careful nodal sampling at the time
of thoracotomy. Their study suffered from the fact that a nodal sampling
scheme was not used in correlating radiologic and pathologic findings.

The recent meta-analysis of the mediastinal staging by CT evaluated
twenty studies dated 1991 through 2001 with a total of 3,438 patients,
with the vast majority using the short axis diameter \>10 mm as the
criterion for nodal positivity. Citing marked heterogeneity of the
individual studies, the authors reported the pooled sensitivity and
specificity of CT scanning as 57% and 82%, respectively, while the
overall positive predictive value (PPV) and negative predictive value
(NPV) of CT scanning were 56% and 86%, respectively. Furthermore, the
authors concluded there was no demonstrable improvement in accuracy over
the past decade in spite of advances in CT technology.

In summary, controversy still exists about the value of CT scanning in
staging the mediastinum in lung cancer. A negative CT scan for
mediastinal adenopathy may provide useful information, particularly in
institutions in which mediastinoscopy may not be available or preferred.
If patients are selected immediately for thoracotomy without preceding
mediastinoscopy, careful nodal sampling must be done at the time of
surgery. Because of the low specificity of CT, enlarged lymph nodes must
be biopsied for accurate staging. Despite the limited sensitivity and
specificity of CT, it is used almost universally for staging the
mediastinum in lung cancer. This use appears to be appropriate because
of the additional information it provides, such as a map of enlarged
nodes prior to mediastinoscopy, as well as information on enlarged nodes
that are out of reach of the mediastinoscope or that are contralateral
in position and suspect for N3 disease.

The issue of CT staging of the mediastinum in T1 lesions is
controversial. T1 tumors are defined as lesions \<3 cm in greatest
diameter surrounded by lung or visceral pleura without evidence of
invasion proximal to the lobar bronchus. Several studies have suggested
a low prevalence of mediastinal nodal metastatic disease with T1 cancers
(5%-15%). Because of this low prevalence, it has been suggested that CT
may not be necessary in such patients and that the preoperative staging
should be limited to plain chest radiographs. However, one study found a
21% prevalence of nodal metastasis among 104 patients with T1 lesions.
The sensitivity of CT was 77% for detecting these metastases, and the
study\'s authors recommended that CT be performed in such patients.
Another study of 23 patients with T1 lesions found only one patient who
had CT evidence of noncurative disease. Because of the low yield, CT was
not recommended. In a larger series of 63 patients, the authors found
that 14% of patients with T1 lung cancers had inoperable disease
correctly detected by CT. However, in this study pathologic proof of
inoperability was lacking. In summary, the issue remains controversial,
and none of the studies appears to be definitive.

**Evaluation of Distant Metastasis (the M Factor)**

The role of CT in determining extrathoracic metastasis from bronchogenic
carcinoma is also controversial. There appears to be general agreement
that CT of the thorax should include the adrenal glands, which are a
frequent site of metastases from non-small cell lung cancer. In a study
of 91 autopsy-proven adrenal metastases from lung cancer, the authors
found that the sensitivity of CT was low (41%) but that the specificity
was high (99%). They recommended CT but noted that patients with a
negative CT had a 30% likelihood of adrenal metastasis. The other
potential problem with screening the adrenal glands is the
nonspecificity of the findings. This problem has been documented in
later studies. Another study looked at 330 patients with bronchogenic
carcinoma, 33 of whom had adrenal masses. Only 25% had metastatic
disease, and the remainder had adenomas. Adenomas can often be
distinguished from metastasis by their smaller size and low attenuation
values. However, in many cases, additional imaging with MRI or
percutaneous biopsy is necessary for diagnosis. A similar study
confirmed the nonspecificity of adrenal masses in patients with
non-adrenal primaries.

Bone scintigraphy in the detection of metastatic disease has significant
limitations. Although it has high sensitivity, it is noted for very low
specificity that ranges from 50 to 60%. Bone scintigraphy should
probably be limited to cases in which patients have specified clinical
indicators of bone metastasis. Routine cerebral imaging in the form of
CT is recommended only for patients with stage III disease, particularly
those with adenocarcinoma and large cell carcinoma cell types.

**Magnetic Resonance Imaging**

Initial experience suggests that evaluation of the mediastinum with MRI
is approximately equal to that of CT with regard to the staging of
bronchogenic carcinoma. However, one study showed that MRI was
significantly more accurate for detecting direct mediastinal invasion.
Other studies have confirmed the usefulness of MRI, particularly in the
evaluation of chest wall invasion and the local staging of superior
sulcus tumors. One study showed an accuracy of MRI of 94% compared with
63% for CT in determining tumor invasion through the superior sulcus.
Similarly, another study showed that T1-weighted images had 90%
sensitivity and 86% specificity in detecting chest wall invasion by lung
cancer. MRI is particularly useful in determining certain parameters of
unresectability for superior sulcus cancers, such as invasion of the
vertebral body and involvement of the subclavian artery and brachial
plexus. The general conclusion of these studies is that MRI has
advantages in the assessment of both chest wall and mediastinal
invasion.

**Positron Emission Tomography**

Initial studies of PET imaging in lung cancer using 18-FDG has been
proven it to be clinically useful. In a study of 100 patients, PET
showed sensitivity and specificity \>70% for hilar nodes and \>90% for
mediastinal nodes. Of particular interest was the fact that the negative
predictive value of PET was high, suggesting that a normal PET scan
might obviate the need for mediastinoscopy in these patients. In another
study comparing PET and CT, sensitivities and specificities of \>80%
were achieved with PET, compared with CT sensitivity of 64% and
specificity of 44%. In another study, 47 patients suspected of having
newly diagnosed non-small cell lung cancer were evaluated with both CT
and PET scanning, and each imaging study was evaluated separately, with
nodal stations localized according to the American Thoracic Society
mapping system. The sensitivities of PET and CT were 89% and 57%,
respectively. Specificities were 99% and 94%, respectively. PET had a
negative predictive value of 97%. All of these studies suggest a
superiority of PET over CT for nodal staging of non-small cell lung
cancer.

In a more recent study involving 100 patients, PET staging was accurate
in 83% of patients, while conventional imaging staging was accurate in
65% of them. PET correctly staged mediastinal lymph nodes in 85% of
patients vs. 58% for CT. In an even larger group (167 patients) with
non-small cell lung cancer staged by conventional imaging, PET detected
otherwise unexpected distant metastases in 18% of patients with stage II
disease and 24% of patients with stage III disease, prompting the
authors to conclude that PET staging was indicated for radical radiation
therapy candidates. The multicenter randomized PLUS (PET in lung cancer)
trial, comparing a group of 96 patients staged with conventional workup
with a group of 92 patients staged with both conventional workup and
PET, concluded that \"addition of PET to conventional workup prevented
unnecessary surgery in one out of five patients with suspected non-small
cell lung cancer.\"

The large body of evidence prompted several meta-analyses of the
existing data. In a comprehensive review of current evidence, one
meta-analysis pooled 18 studies conducted between 1994 and 2001 with the
total of 1,045 evaluable patients. The authors found that the summary
receiver operating characteristic (ROC) curve was significantly more
accurate for PET than for CT (p\<0.001), with a pooled sensitivity of
88% and a sensitivity of 89%. The PPV and NPV were 79% and 93%,
respectively.

Availability of PET has improved dramatically in recent years. With over
1,000 cameras installed in North America in 2004, it is now feasible to
include PET in the routine staging of lung carcinoma. Indications for
whole body FDG PET in patients with non-small cell lung cancer include
high clinical index of suspicion, high grade malignancy, and
radiographic evidence of nodal enlargement. In addition, PET may be
helpful in centers where mediastinoscopy is not readily available and in
patients with significant comorbid conditions who are borderline
candidates for surgery, with locally advanced disease, solitary brain
metastasis, and cases of local recurrence that might qualify for
reoperation.

**Small Cell Lung Carcinoma**

According to the recent analysis of the Surveillance, Epidemiology, and
End Results database, small cell lung cancer (SCLC) now accounts for
about 14% of all new cases of lung cancer. It is more aggressive than
the non-small cell form, with median survival of 2-4 months if
untreated. Although the TNM staging system has been useful, the
alternative staging system widely applied is a two-stage system based on
studies of the Veterans Administration Lung Study Group. In this system,
patients are classified as having either limited disease (i.e., tumor
confined to one hemithorax and to the regional lymph nodes) or extensive
disease (i.e., tumor beyond this area in contralateral lung or
extrathoracic sites). Extensive disease is present in 60 to 80% of
patients newly diagnosed with SCLC. Conventional staging for
extrathoracic metastasis in patients with SCLC includes CT of the
abdomen, CT or MRI of the head, and bone scintigraphy. A bone marrow
biopsy may be omitted for patients with normal blood counts, normal
lactate dehydrogenase level, and negative result on bone scan. Other
routine staging procedures include liver function tests and complete
blood counts.

*Noninvasive imaging is generally recommended only in patients who have
abnormal routine screening tests*. One study compared CT and ultrasound
(US) in staging the abdomen in patients with SCLC. They found that CT
was more sensitive than US and showed 50% of patients with extensive
disease compared with 39% by US. Twenty percent of patients were
restaged as a result of the CT findings. These authors, however,
recommended that CT of the abdomen only be performed in patients with
biochemical abnormalities. In regard to the search for central nervous
system (CNS) metastasis, again the recommendation is that routine brain
CT or MRI only be done for patients involved in clinical study
protocols. The remainder should be limited to patients with symptomatic
or clinically detectable CNS metastasis. Another study attempted to
determine the value of routine CT of the brain in patient with SCLC
compared to neurologic findings. Of a total of 57 patients, both with
and without neurologic symptoms, only four had brain metastasis, and
three of these patients had the metastasis confirmed by CT. In the one
negative patient, CT was later found to be positive. All of these
patients were symptomatic or had positive neurologic examinations. Of
the 54 non-neurologically symptomatic patients, no metastases were
detected on CT.

As with NSCLC, skeletal metastasis may be evaluated with bone scanning.
Although highly sensitive, bone scanning has a low specificity in SCLC,
as it does in NSCLC. Screening is best limited to patients with symptoms
or abnormal biochemical profiles. A preliminary study of 25 patients
examined the value of MRI in staging SCLC. The MRI resulted in a change
in staging in 5 of the 25 patients. These patients were found to have
extensive disease. Additional metastases were found in the bone and
liver as a result of the MRI. However, details on the clinical studies
on these patients are not available in this study, and the work appears
to be too preliminary to allow any recommendation on the use of MRI in
the staging of SCLC.

Several new prospective studies addressed the utility of PET in staging
SCLC, each in a relatively small group of patients. All concluded that
FDG-PET has high sensitivity for SCLC and appears to be of value in
staging SCLC. In a larger prospective series, FDG-PET caused stage
migration in 14 of 120 patients, with 10 being correctly upstaged and 3
correctly downstaged. All stage changes affected management. Only one
patient was incorrectly staged by PET due to failure to detect brain
metastases. In this study, the sensitivity of FDG-PET was found to be
significantly superior to that of CT in the detecting extrathoracic
lymph node involvement (100% vs. 70%) and distant metastases except to
the brain (98% vs. 83%). PET was significantly less sensitive than CT/MR
for detecting brain metastases (46% vs. 100%). Although these results
appear promising, more data are needed to unequivocally establish the
role of PET in staging SCLC.

**Abbreviations**

-   CT, computed tomography

-   FDG PET, fluorodeoxyglucose positron emission tomography

-   MRI, magnetic resonance imaging

-   NUC, nuclear medicine

-   PA, posteroanterior

#### CLINICAL ALGORITHM(S)

Algorithms were not developed from criteria guidelines.

### 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 bronchogenic carcinoma, non-small cell and small cell lung
carcinoma

#### POTENTIAL HARMS

Not stated

### 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)

Rozenshtein A, Davis SD, Ritsuko RU, Bradley JD, Gopal RS, Haramati LB,
McLoud TC, Movas B, Rosenzweig KE, White CS, Kaiser LK, Schiller JH,
Expert Panel on Thoracic Imaging and Radiation, Oncology-Lung Work
Group. Staging of bronchogenic carcinoma. \[online publication\]. Reston
(VA): American College of Radiology (ACR); 2005. 9 p. \[42 references\]

#### ADAPTATION

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

#### DATE RELEASED

1996 (revised 2005)

#### 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 Thoracic Imaging
and Radiation Oncology-Lung Work Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Anna Rozenshtein, MD (*Principal Author*); Sheila D.
Davis, MD (*Panel Chair*); Ritsuko U. Komaki, MD (*Lung Work Group Panel
Chair*); Jeffrey D. Bradley, MD; Ramesh S. Gopal, MD; Linda B. Haramati,
MD; Theresa C. McLoud, MD; Benjamin Movas, MD; Kenneth E. Rosenzweig,
MD; Charles S. White, MD; Larry R. Kaiser, MD ; Joan H. Schiller, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This updates two previously published versions: McLoud TC, Westcott J,
Davis SD, Fleishon H, Gefter WB, Henschke CI, Pugatch RD, Sostman HD,
Tocino I, White CS, Yankelevitz D, Bode FR. Staging of bronchogenic
carcinoma, non-small cell lung carcinoma. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215 (Suppl):611-9 and
Ko B, Sause WT, Byhardt RW, Curran WJ, Fuller D, Graham MV, Komaki R,
Weisenburger TH, Kaiser LR, Leibel SA, Brown RC. Staging of non-small
cell lung carcinoma. American College of Radiology. ACR Appropriateness
Criteria. Radiology 2000 Jun;215(Suppl):1281-94.

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/ExpertPanelonThoracicImaging/StagingofBronchogenicCarcinomaDoc11.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 is 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/pdf/background_dev.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on March 6, 2006.

#### 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

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Date Modified: 11/3/2008