Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging
Phase: NA
Conditions: PET Imaging
Sponsor: University of Cincinnati

 
Protocol Title: 
Assessment of Investigational Positron 
Emission Tomography and Post-Processing 
Procedures Performed as add-ons to Standard of 
Care Imaging 
Protocol Date: 
December 20, 2017 
Research Project Number: 
RP0689 
Principal Investigator: 
Michael V. Knopp, MD, PhD 
Professor of Radiology and Novartis Chair of 
Imaging Research 
Vice Chair of Research, Department of 
Radiology 
395 West 12th Avenue, 4th Floor 
Columbus, OH 43210 
Knopp.16@osu.edu 
Office: 614-293-9998 
Fax: 614-293-9275 

PI: Michael V. Knopp, MD, PhD 
RP0689 
 
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I. Objectives 
 
The purpose of this study is to utilize investigational Positron Emission Tomography (PET) imaging 
acquisitions in addition to standard of care imaging: 
 
1. To develop and refine PET post-processing acquisition procedures. 
2. To generate preliminary and comparative imaging data for potential clinical trials. 
3. To retrospectively evaluate standard of care PET imaging acquisitions by comparison with 
investigational PET imaging acquisitions. 
 
II. Background and Rationale 
 
PET imaging is increasingly being used as a diagnostic modality in cancer detection, staging and 
response assessment. Additionally, PET imaging is utilized in the detection and assessment of 
neurodegenerative or neurofunctional diseases, cardiovascular diseases as well as inflammatory 
processes. Constant advances in imaging acquisition and post-processing approaches enable a large 
variability of acquisition settings that can only be evaluated in real clinical situations with comparison 
to current standard of care imaging. We are proposing in this research only to use modified PET 
acquisition and post-processing approaches that do not lead to any additional radiation exposure or 
other risks to the patient. 
 
III. Procedures 
 
A. Research Design 
 
The prospective portion of this study will utilize investigational PET acquisitions in addition 
to standard of care PET imaging to develop and optimize PET acquisition post-processing 
techniques as well as to generate preliminary and comparative data for potential clinical trials. 
These post- processing techniques include but are not limited to visual inspection of lesions, 
normal tissue, sentinel nodes and imaging artifacts, semi-quantitative analysis including the 
use of rating schemes, and using various published methods for image post-processing. The 
PET methodologies we plan to use as part of this study will allow us to obtain morphological, 
functional and molecular information. 
 
Patients receiving a standard of care PET will be asked by study personnel if they are interested 
in undergoing additional investigational acquisitions before or after their standard of care 
imaging. If the patient agrees, he/she will remain on the same PET scanner for up to an 
additional 30 minutes while more images are obtained. Each patient will be imaged for no 
longer than 2 hours (standard of care imaging and additional investigational imaging). A 
routine clinical report will be generated for the clinically indicated PET by a nuclear medicine 
physician. Once this routine clinical PET scan is dictated and finalized, a study team member 
will obtain the report via IHIS and manually remove all identifiers. This report is being 
obtained for comparative purposes. All the data being compared will be coded using a unique 
study number. 
 
Patients will be asked to provide study personnel with authorization to their medical records 
for follow-up on future related procedures as well as the current outcome of their imaging 
procedure. Additionally, participants will be asked if their imaging data from this study can be 

PI: Michael V. Knopp, MD, PhD 
RP0689 
 
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used in a de-identified manner in the future for comparison with other imaging data or as 
preliminary data for the protocol development of clinical trials. 
 
The retrospective portion of this study will involve the review of pre-existing PET imaging data 
collected from January 1, 2001 through December 5, 2017. The data to be reviewed/analyzed includes 
PET imaging data that has been previously collected in the course of standard clinical care. The PET 
imaging acquisitions obtained from the retrospective review will be utilized as a comparison to the 
investigational images obtained during the prospective portion of this study. The criteria that will be 
utilized to determine how the retrospective data will be utilized includes the following parameters: 
type of imaging study, diagnosis, age in decades, gender, and availability of data in the imaging 
archive. 
 
B. Sample 
 
The prospective portion of the study population will include 200 evaluable patients receiving a 
standard of care PET scan at The Ohio State University (OSU). Potential participants will be 
identified by study team members at the time of the patient’s standard of care imaging procedure. 
 
Inclusion Criteria: 
 Male and female volunteers greater than or equal to 18 years of age. 
 Patients receiving a standard of care PET scan at OSU. 
 
Exclusion Criteria: 
 Participants who are pregnant or lactating. 
 Prisoners. 
 Subjects incapable of giving informed written consent. 
The retrospective portion of the study population will include up to 500 evaluable previously 
acquired and archived standard of care PET scans. The selection of the cases will be based on 
availability of a data set and match in disease or age or gender to cases of the prospective 
population. All retrospective datasets will be de-identified using an established approach that is 
detailed below. 
 
Inclusion Criteria: 
 Patients having receiving a standard of care PET scan that is archived at OSU. 
 
C. Measurement / Instrumentation 
 
Studies will be carried out using FDA approved PET scanners. PET is routinely used for 
clinical diagnostic studies. 
 
D. Detailed study procedures 
 
In the prospective portion, written informed consent will be obtained from each participant 
prior to any protocol related activities in a private area with a study team member. As part of 
this procedure, study personnel will approach eligible participants and explain verbally and in 
writing the nature, duration, and purpose of the study as well as all associated risks and 
benefits. They will inform the participant that he/she may withdraw from the study at any time. 

PI: Michael V. Knopp, MD, PhD 
RP0689 
 
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The patient will be given time to ask questions and review the consent form on their own. 
During the consent process, the patient will be asked if he/she 1) is willing to provide a release 
of their medical records pertaining to future procedures/injuries in the next 10 years and 2) is 
willing to allow their de-identified data to be used as comparison data in other research studies 
or as preliminary data for the development of clinical trials. If the patient agrees, he/she will 
have additional PET acquisitions before or after their standard of care PET imaging. The 
patient will remain on the same PET scanner for all acquisitions. The investigational imaging 
will take no longer than 30 minutes. Each patient will be imaged for no longer than 2 hours 
(standard of care imaging and additional investigational imaging). 
 
In the retrospective portion of the study, all PET/CT imaging data will be downloaded from the 
imaging PET Grid or archive system to the dedicated imaging corelab service where the 
imaging data will then be de-identified and referenced only by a study ID number. We will 
retain / code the following information regarding the data so that we may use it comparatively 
with matched investigational PET imaging data: type of imaging, diagnosis, coded imaging 
exam date, gender, age in decades, weight in 20 pound increments, and height in feet increments 
(i.e. excluding inches). 
 
The date of the exam will be coded to the first day of the quarter when the study was performed, 
except in cases where follow up studies are performed at a shorter time interval. If a shorter time 
interval exists, the date will be coded in relation to the baseline study that will be coded as the 1st of 
the quarter. For example, a baseline CT scan was performed on 10/5/2017 with a follow up on 
10/7/2017, and the date coding would be 10/1/2017 for the baseline and 10/3/2017, preserving the 
relative time ratio within the quarter, but changing the date to a coded date. 
 
Image Collection: 
All patients in the prospective portion of this study will receive a standard of care 
PET. Patients will be asked to simply lie on the table of the PET system for the duration of 
clinically indicated PET. Subjects participating in the additional investigational imaging 
sequence will be asked to lie on the table for an additional 30 minutes before or after 
standard of care imaging while acquisitions are obtained. Participants will not participate in 
more than a total of 2 hours of imaging time per day because they will become uncomfortable 
lying still in one position and motion compromises the image quality. 
 
Release of Medical Records: 
The patient will be asked if he/she is interested in releasing their medical records for up to 10 
years after their participation in this study in order to allow study personnel to track the current 
outcome and/or related procedures in the future. The patient can revoke their consent to this 
question at any time by contacting the Principal Investigator 
 
Additionally, patients will be asked if their de-identified data can be used for other research 
studies as comparative or preliminary data. The patient can change their response to this 
question at any time by contacting the Principal Investigator. 
 
E. Risks, Benefits, Safety and Confidentiality: 
 
The patient will be injected with a radiopharmaceutical for the standard of care PET imaging 
procedure. The patient will not receive any additional radiation from the investigational 
imaging acquisitions obtained. 

PI: Michael V. Knopp, MD, PhD 
RP0689 
 
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Risks: 
There are no additional safety risks associated with the investigational PET imaging. 
 
Benefits: 
It is hoped that the information from this study will initiate changes in the field of view, changes 
related to table movement and changes due to detector settings such as energy window. 
 
Safety Monitoring: 
As part of the standard of care imaging procedure, safety monitoring measures on the patients. 
This will include the monitoring of the physiologic parameters that are deemed appropriate in 
the evaluation of potential risk during the acquisition process (electrocardiogram, respiration 
rate, core body temperature). These parameters are monitored to ensure that they do not 
approach potentially hazardous levels. The Principal Investigators or Co-Investigators are able 
to respond immediately to ensure the safety of the patients participating in the research study. 
The Principal and/or Co-Investigators or Key Personnel will be present at the time of all PET 
acquisitions to ensure this. 
 
Patient participation maximum duration and frequency is defined by protocol as follows: 
Duration of data acquisition in the PET system per patient is limited to no more than 2 hours 
total per day consisting of one or more acquisitions. 
 
In the event of any medical emergency, accident or trauma while the subject is in the 
laboratory, our contingency plans for emergency situations are as they would be for any 
medical facility and clinical magnetic resonance imaging facility. Our emergency protocol 
fully prepares us to provide access to emergency treatment for our patients, resuscitation, life 
support and medical care as needed. 
 
Confidentiality of Records: 
All paper and electronic data/information will be de-identified prior to any review or analysis. 
All paper documents will be stored in a locked file cabinet with limited access in the 
Department of Radiology at The Ohio State University. All electronic data obtained through 
PACS or IHIS will be stored in a de-identified manner on password protected servers with 
limited access in the Department of Radiology at The Ohio State University. In the Informed 
Consent, we are asking subjects for release of medical records for up to ten years, as well as 
the use of de-identified data for other future studies. This data will become part of the 
permanent archive of the Wright Center of Innovation and may be kept indefinitely. No 
individual identities will be used in any publications resulting from this study. If the subject 
has authorized the use of de-identified data for other research studies as comparative data, the 
de-identified data may be shared with collaborative investigators as well as research databases. 
The established processes to verify de-identified data will always be adhered to. Officials from 
examining bodies such as the U.S. Food and Drug Administration or NIH may inspect records 
pertaining to this study. 
 
F. Internal Validity 
 
Image data will be evaluated following standard published procedures. This includes but is not 
limited to visual evaluation of lesions, normal tissue, sentinel nodes and imaging artifacts, semi- 
quantitative analysis including the use of rating schemes, and using various published methods for 
image post-processing. This should ensure internal and external validity of the data and avoid 
study bias. Functional and molecular read outs will be established according to methodologies. 

PI: Michael V. Knopp, MD, PhD 
RP0689 
 
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G. Data Analysis 
 
As the purpose of this data is to demonstrate feasibility in real life applications, we do not intend 
to perform a statistical assessment beyond classifying the characteristics of pilot data and 
comparing observational trends either to the standard of care imaging data or other known reference 
data. For our purposes, imaging that presents lower imaging quality will not be pursued for further 
evaluation. Only images that suggest equivalent or improved image quality would be evaluated for 
the potential use of preliminary data toward a formal Phase I/II clinical trial.