Patterns and Prevalence of 18F-2-fluoro-2-deoxy-D-glucose (FDG) Extravasation in Positron Emission Tomography (PET)/ Computed Tomography (CT) Scans
Phase: NA
Conditions: Intravenous Infiltration
Sponsor: St. Louis University

The attached document is the study protocol included for the following protocol: 
Title: Patterns and Prevalence of FDG Extravasation in PET/CT Scans (Lucerno device)  
ClinicalTrials.gov NCT03041090 
Document Date: February 14, 2017 

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
----------------------------------------------------------------------------------------------------
X
7.
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
The participant completes a questionnaire for research purposes.
 
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.
 
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new subjects;
(ii)
All subjects have completed all research-related interventions; and
(iii)
The research remains active only for the long term follow-up of subjects.
 
b)
Previously approved research where no subjects have been enrolled and no additional
risks have been identified.
 
c)
Previously approved research where the remaining research activities are limited to data
analysis.
 
9.
 [FOR IRB use only]. Continuing review or research not conducted under an investigational new drug
application or investigational drug exemption where expedited categories two (2) through eight (8) do
not apply but the IRB  has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been identified.
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* * * Background, Purpose, Study Procedures * * *
Title
Patterns and Prevalence of FDG extravasation in PET/CT scans
 
Complete Sections 1 - 16. In sections that allow reference to sponsor protocol or grant, clearly state section and
page numbers. Any information that is different or specific to the local site should be in the SLU application.
Specify N/A as appropriate. Do not leave any required sections blank.
1. Background
 
     Page numbers from a sponsor's protocol/grant may be referenced in 1a and 1b.
 
  
  
a)  
Provide an introduction and background information. Describe past experimental and/or clinical
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must
cite references in the response provided or attach a bibliography.     *<a
href="javascript:showPopUpdata('HELP','Application Consideration:
In this question the IRB requires a brief introduction with supporting background information to
describe your study. Do not include overly lengthy descriptions.

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
----------------------------------------------------------------------------------------------------
Investigator Initiated studies (i.e., the Principal Investigator has conceived, designed, and is
conducting the research) are required to cite references in the response or should upload a
referenced bibliography in the Attachments section.')">?HELP?*
With the commercialization of the first PET/CT scanner in 2001, this technology has played an
ever increasing role in oncology, neurology, cardiology, and other applications. PET with 18F-
FDG is used to diagnose, stage, and restage many cases of cancer; the accuracy ranges from
80% to 90% and is often better than that of anatomic imaging (1). Since the introduction of
PET/CT, numerous studies have shown that this whole-body dual- technique imaging is better
than PET or CT alone for staging and restaging most cases of cancer. The improvement in
accuracy coupled with the convenience of presenting anatomic and functional information to
physicians has rendered PET/CT the most important cancer imaging technique at present (2).
Furthermore, the use of PET/CT has been advocated as a first-line imaging technique for
whole-body tumor staging, restaging, and assessing response to therapy for different types of
neoplasms (3). Since changes in FDG accumulation have been shown to be useful as an
imaging biomarker for assessing response to therapy (4), PET/CT scanning through this
combination of molecular and anatomical imaging is playing an ever increasing role as a way to
quantitatively measure individual response to therapy and to even evaluate new drug therapies.
(5) The standardized uptake value (SUV) is commonly used as a relative measure of the
labeled tracer uptake.  The SUV is a ratio of the radioactivity concentration in an area of interest
to the decay corrected amount of radiolabeled tracer divided by the patients weight in grams. It
is believed that the two largest factors that influence SUV are: injected dose and patient size.
(5)
Primary factors that impact the delivered dose of FDG include: the uptake duration between
injection and scan, residual syringe activity measurement, dose extravasation (also referred to
as infiltration) near the injection site, patient weight measurement, clock synchronization for
measuring dose assays and scanning, and data entry.
An extravasation or infiltration is a common problem that can occur when the radio-labeled
tracer infuses the tissue near the venipuncture site, and can result from the tip of the catheter
slipping out of the vein or passing through the vein. Additionally, the blood vessel wall can allow
part of the tracer to infuse the surrounding tissue. As a result, the radio-labeled dose being
delivered is inaccurate and as Kinahan has pointed out the accuracy of the calculated dose is
critically important to the SUV calculations; errors in an SUV calculation in one assessment
scan can severely impact patient treatment and research conclusions.
Extravasations/infiltrations may in fact contribute to the wide variability in researcher’s efforts to
characterize SUV thresholds for clinical decision making. Velasquez found that the “thresholds
for metabolic response in the multicenter multiobserver non-QA settings were -34% and 52%
and in the range of -26% to 39% with centralized QA”. (6) In local practices and even in
practices and research centers employing Quality Assurance checks, these issues with SUV
calculations have left oncologists and researchers needing to see significant changes in SUV
values to be somewhat assured they are making sound treatment decisions or reaching proper
research conclusions.
While there is very little published information on FDG extravasation rates, they are not
insignificant and the impact on SUV is not fully characterized.  Thus, this study hopes to look at
the frequency and patterns of extravasation episodes to better characterize their effect on SUV
values.
AuthorJournalYearNInf RateComments
Hall, et al (7)
Ohio State UJ Nuc Med200619021% (39)Prospective
Krumrey, et al (8)
St Louis UJ Nuc Med200998
983% (3)
9% (9)Using automated injector

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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Manual injection
Osman, et al (9)
St Louis UFrontiers in Oncology201140010.5% (42)Retrospective
Silva-Rodriguez, et al (10)
U Santiago, SpainMed Physics20141,36718%Retrospective
 
Please save frequently
 
  
  
b)  
Describe any animal experimentation and findings leading to the formulation of the study, if
there is no supporting human data.
In oncology, whole-body PET/CT is typically performed from the head to the pelvic floor
[7](eyes to thighs). The use of the term whole-body is misleading because the most commonly
used field of view (FOV) for arms-up whole-body PET/CT protocols includes only the base of
skull to the upper thighs and does not include the brain, skull, and large portions of both upper
and lower extremities. In such FOV, the most commonly used site of injection, namely the
antecubital fossa (inside of the elbow), is frequently not included in the imaging field. In the
Frontiers in Oncology article, Osman also determined that based on the commonly used FOV
at most PET/CT centers, that when infiltration is present, it may be unnoticed by clinicians in
approximately 31% of the cases. (7)  [See sources for citations on previous question]
Lucerno Dynamics, a privately held company in North Carolina, has also discovered that the
static image may be incapable of reporting on the quality of FDG administration during the ~60
minute uptake period. Lucerno’s system has been used in two investigational studies at two
centers. At one center, the system was used with 8 patients for a total of 15 scans. At the other
center, the system was used with 40 patients for a total of 85 scans. Similar rates of infiltrations
were found to those described in the published articles. Based on this experience, Lucerno has
found that infiltrations can partially resolve during the uptake period, so that even if they are
visible in the PET image, the image may not reveal the extent of the infiltration. This could
severely and negatively impact research and therapy decisions and thus patient outcomes.
The Lucerno devices (Lucerno ID) are nonsignificant risk devices that add only 2-3 minutes to
the current standard of care PET/CT scanning process. Lucerno ID sensors are applied to the
patient’s skin before the injection of the radiotracer and are removed after the FDG uptake
period and prior to the PET/CT imaging process. The Lucerno ID has the ability to identify
infiltrations, whether they are within or outside the FOV of reviewing clinicians, and can alert
clinicians before their patient undergoes a compromised PET/CT scan due to the infiltration.
This technology can prevent patients from receiving the additional CT radiation exposure of a
compromised scan, can save cost, and can improve patient outcomes by ensuring more
accurate PET scan interpretation.
 
2. Purpose of the study
 
  
  
a)  
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
PET (Positron Emission Tomography) images are used to help make patient management
decisions in staging and treatment assessment, often after a cancer diagnosis.
Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is
known as extravasation or infiltration, and it compromises the doctor's ability to read the PET
image. Often, the site where the tracer is injected into the vein (usually in the inside of the
elbow) are not in the images taken, so reading physicians are unaware that an extravasation
has occurred.

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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Technology exists to capture time activity curves (amount of tracer in a location over a period of
time) during the PET tracer uptake period (usually once the tracer is injected, the tracer
circulates for 60 minutes prior to images), which can enable physicians to accurately detect
extravasations. This  information is currently unavailable to physicians reading routine PET/CT
scans.
Time activity curves information gathered from these sensors during the circulation period
appear to match the brief pictures taken approximately 70 minutes after the tracer injection.
This study will determine if these time activity curves correspond to PET images of the injection
site taken during the tracer uptake period.  If time activity curves correspond to PET images,
they can be used to determine if the tracer was properly injected. If there was an improper
injection, clinicians can be alerted to this fact and interpret the image with this additional
information.
 
     Page numbers from a sponsor's protocol/grant may be referenced in 2b and 2c.
 
  
  
b)  
List your research objectives (specific aims & hypotheses of the study).
The study will try to answer the following questions:
•How often do infiltrations of FDG occur in routine PET/CT imaging?
•Can the Lucerno ID (sensor device) accurately determine the presence or absence of an
extravasation as confirmed by PET imaging?
•Can patterns be identified in the conditions that tend to lead to extravasation?
•Is there a way to quantify the impact of an extravasation on the injected dose, and thus the
SUV calculation?
Our hypothesis is that the Lucerno ID device accurately captures dose extravasations. Data
extracted from Lucerno ID may help quantify extravasation and, in so doing, may allow for
developing correction factors for measured SUV.
 
Please save frequently
 
  
  
c)  
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.). If the study is investigator-initiated, a timeline for individual subject
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be
randomized.
Investigator initiated, non blinded, experimental, non-randomized study
 
  
  
d)  
If subjects will be given placebo, please justify placebo use.    *?HELP?*
N/A
 
3. Study Procedures
 
    a)
N
Is this project a multicenter study (i.e., same project is conducted elsewhere by a
different investigator) OR does this study involve conduct of research at multiple sites?
      
Is SLU acting as a coordinating center for other sites OR is the SLU PI a direct recipient
of a federal grant for this research? If yes, complete and attach the  Supplemental

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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Application for Coordinating Center Activities.
      
Will the SLU site be participating in all parts/procedures/arms of the study?
   
    
    
If No, explain what SLU will NOT participate in:
 
Please save frequently
 
Page numbers from a sponsor's protocol/grant may be referenced in 3b, 3c, and 3d.
 
  
  
b)  
Describe all the procedures, from screening through end-of-study, that the human subject must
undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care. Specify which procedures are for research and
which are standard of care. Please note: The box below is for text only. If you would like to add
tables, charts, etc., attach those files in the Attachment section (#16).
Patients will be identified once they arrive for their standard of care PET/CT exam.  If it is
determined there is time and a sensor device is available, a subject will be asked about interest
in participation.  If they are interested, an informed consent dialogue will occur between patient
and engaged team member such as a PET technologist, physician, or research coordinator.
The informed consent document will be signed and retained  (behind two locks) by engaged
members of the research team.  This includes the PI, other investigators (MDs), engaged PET
technologists and/or the research coordinator.
Once consent is obtained the patient will continue on with the standard of care screening
process (name, DOB, height, weight, eating status, etc. will be obtained for the standard of care
PET/CT exam).  Lara Systems is planned for use once we get this system which is planned for
the week of 10/17/2016. Our plan would be to still use the LD1 ID until we get the Lara device
or as a back up if the Lara device is not working properly.  Just before the radioactive FDG is
injected, the four sensors (injection site, contralateral arm - similar position to injection site,
liver, and over the subclavian area) on the Lucerno ID device will be placed on the subject by
the PET/CT technologist.  The device sensors will remain in place for the FDG uptake period
(typically 60-90minutes).  The patient will be lying on the scanning table or in a reclined chair for
this uptake period, depending on the availability of the imaging table.  During the uptake period,
if the scanner and imaging table are available, the subject will have dynamic PET only images
taken to correlate sensor data with imaging.  This is not a necessary part of the protocol and
will only be performed if the scanner is available.  If the PET/CT scanner is not available, the
sensors will be placed in the same locations and at the end of the uptake period, sensor only
data will be retained  After the uptake time is complete, the sensors will be removed by the
technologist and the patient will proceed on with their standard of care PET/CT imaging.  The
patient will not receive any extra radiation due to the study and should only add 5 minutes to
the time of their PET/CT scan.
The study team will then upload the sensor data to a PC in the PET/CT department where it will
be coded and sent to Lucerno Dynamics via a software for analysis.  If requested, the coded
PET data obtained during the uptake phase (no additional radiation involved with this imaging)
will be complied and shared with Lucerno Dynamics.  The patient will also be asked to
complete a quick survey on the comfort of use for the Lucerno ID device.  This coded paper
survey will be shared with Lucerno Dynamics for further development of this device.
 
  
  
c)  
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is
compared to a placebo group or comparison treatment group, what are the guidelines or
endpoints by which early decisions regarding efficacy or lack of efficacy can be made? For
example, it may be reasonable to stop enrollment on a study when efficacy has already been

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated,
given the statistical power of the study as designed. Describe the guidelines that are in place to
assist in making these determinations, if relevant to the proposed study.
This study does not include a control group, so there will be no comparison or efficacy
measured.
d)
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest group/unit for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide
references. For full board, unfunded studies describe sample size determination and power
analysis. If none, please justify.
The coded data (information will have study number only) will be reviewed by Lucerno 
Dynamics individually after each patient to look for quality.  The quality will be reviewed to 
assess the injection site data visually and with time activity curves. Interval analysis will be 
done once significant recruitment has been achieved and reported if seen fit by SLU and 
Lucerno Dynamics.  The data will be reviewed to look at group data and injeciton quality. 
Please save frequently
e)
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If
so, describe the nature of the deception and provide a rationale for its use. Also, describe
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using
deception, an alteration of consent must be justified in the Informed Consent section of the
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section
(#16). <a href=http://www.slu.edu/Documents/research/irb/Deception_Incomplete.doc
target=_blank > See IRB Deception Guidelines.
f)
Is there an accepted standard of care and/or standard practice at SLU for the
condition/disease/situation being studied? This information will assist in comparing
the risk/benefit ratio of study procedures relevant to usual care that would be
received outside of the research context. *?HELP?*
N
If yes, please describe the standard of care and standard practice at SLU for the
condition/disease/situation being studied.
g)
Does this study involve any diagnostic imaging, labwork or genetic testing that could
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could
include discovery that is expected (related to the research) or incidental (not related
to research aims, but possible, like a mass/shadow found in imaging despite not
looking for it).
Y
If yes, please describe and include whether there are plans to share findings with study
participants.
This would be rare as these are additional images in the same location as the standard of care
images; however, this is always a possibility with additional imaging.  If something unexpected
or unknown is discovered on the images, the reading physician will review with the Primary
Investigator and inform the referring physician.

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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    h) 
Is this study subject to the NIH Genomic Data Sharing Policy?
The NIH GDS policy applies to all NIH-funded research that generates large-scale
human genomic data as well as the use of these data for subsequent research and
includes: genome-wide association studies (GWAS), single nucleotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
metagenomics, epigenomic and gene expression data, irrespective of NIH funding
mechanism. Click here for more specific examples.
N
 
---------------------------------------------------------------------------------------------
* * * Radioisotopes or Radiation Machines * * *
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes
information, please select the option to enable this section.
 
4.  Radioisotopes or Radiation Machines
 
In this section, investigators must enter all radiation usage associated with the protocol.
 
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA",
"Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases,
submission to the RSO/RSC should occur first, even before submission to IRB. For more information on how to
submit for radiation safety review, see RSC  instructions or contact the Radiation Safety Officer at 977-6895.
 
(1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section,
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this
guidance.
 
 
a) 
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with
this protocol by clicking "Add" and adding to Table 1 below. (Includes X-ray, fluoroscopy, CT,
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife
procedures, etc.)
 
1. Radiation Procedure:
PET/CT
2. Total number of exams:
1
3. Are the procedures being performed as a normal part of the clinical
management for the medical condition that is under study SOC (Standard
of Care)?
Y
 
If yes, specify the number of exams for each listed procedure that are
SOC.
1
 
NOTE: If all procedures are SOC (i.e., #2 and #3 are the same), you are finished with this procedure
box. If there are procedures that are NOT SOC, proceed with this section.
4. Are the procedures being performed because the research subject is
participating in this project (e.g., extra CT scans, more fluoroscopy time,
additional Nuclear Medicine Studies, etc.), i.e., Not Standard of Care?
N

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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If yes, specify the number of exams for each listed procedure that are NOT
SOC.
5. Estimated Effective Dose per Procedure (mrems):
0
 
Specify the estimated effective dose for each procedure that is NOT SOC. You may use data from the
DUKE Radiation Safety Committee Website:
Adult Patients:  CLICK HERE.
 Pediatric Patients:  CLICK HERE.
 Use of additional references that may provide a higher degree of accuracy of radiation dose estimates
for procedures at Saint Louis University Hospital are encouraged. All references, including use of the
Duke website, must be specified below.
6. Effective Dose Subtotal (mrems):
 Calculated by multiplying the Number of procedures that are NOT SOC
(question #4) by Estimated Effective Dose per Procedure (question #5).
0
7. References. Specify the resource/reference used for estimating the dose for this procedure.
 
 
b)
 Total estimated research radiation dose * :
N/A
 
     
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures.
 
 
 
NOTE: Informed Consent Radiation Exposure Risk Statement- The applicant must insert the appropriate
Informed Consent Radiation Exposure Risk Statement template language into the SLU IRB Informed Consent,
inclusive of applying the total estimated research radiation dose specified in item b) from the table above, as
instructed in the SLU IRB Informed Consent Template. Contact the IRB Office at 977-7744 or irb@slu.edu with
any questions.
 
 
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* * * Devices * * *
5. Devices
 
 a) Please list in the space below all investigational devices to be used on subjects during this study.
 
 
 b) Please list in the space below all FDA approved devices to be used on subjects during this study.
 
FDA Approved Devices

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Biomedical Research
Saint Louis University
Protocol # 26741
Osman
Protocol Title:
Patterns and Prevalence of FDG extravasation in PET/CT scans
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Device Name
Manufacturer
Provide IDE #. Documentation
of IDE # required unless
imprinted on sponsor protocol
(attach in section #16).
Lucerno ID
Lucerno Dynamics
1.
Device Name
Lucerno ID
2.
Manufacturer
Lucerno Dynamics
3.
Describe the device to be used and attach the device manual in section #16.
Lucerno ID device is made by Lucerno Dynamics and is a lightweight sensor that can adhere to skin
and obtain radioactive counts. Lara is also a device made by Lucerno Dynamics and is a lightweight
sensor that can adhere to skin and obtain radioactive counts. The LD1 and Lara Lucerno devices
(Lurcerno ID) are both attached to the subject in the same manner and are considered non-significant
risk.
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
document titled 2015-02-17 NSR
Determination_signed.pdf
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
N
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
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* * * Drugs, Reagents, Chemicals, or Biologic Products * * *
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents
Pilot
Phase I
Phase II
Phase III
Phase IV
Not Phased
 
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not
need to be listed.