Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT

Study Overview
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Brief Summary
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The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.

Detailed Description
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Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG). This early phase trial intends to accomplish the following: to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability; to confirm that a low dose approach will be feasible for response assessment; to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.

Official Title
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Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT

Conditions
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PET/CT Imaging

Intervention / Treatment
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* Diagnostic Test: PET/CT scan with 13 mCi radiation dose
* Diagnostic Test: PET/CT scan with 5 mCi radiation dose
* Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose
* Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose
* Diagnostic Test: PET/CT Scan with not yet determined radiation dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients greater than or equal to 18 years of age Patients scheduled for a standard of care PET/CT scan For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met Exclusion Criteria: Participants who are pregnant or lactating Prisoners Participants incapable of giving informed consent Patients unable to lie flat on the scanner for extended periods of time

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub-Study A<br>Patients receive PET/CT scan on Gemini Astonish PET/CT | Diagnostic Test: PET/CT scan with 13 mCi radiation dose<br>* 13 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT scan with 5 mCi radiation dose<br>* 5 mCi 18F-FDG dose<br>|
| Experimental: Sub-Study B<br>Patients receive PET/CT scan on Biograph mCT | Diagnostic Test: PET/CT scan with 13 mCi radiation dose<br>* 13 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT scan with 5 mCi radiation dose<br>* 5 mCi 18F-FDG dose<br>|
| Experimental: Sub-Study C<br>Patients receive PET/CT scan on Discovery PET/CT | Diagnostic Test: PET/CT scan with 13 mCi radiation dose<br>* 13 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT scan with 5 mCi radiation dose<br>* 5 mCi 18F-FDG dose<br>|
| Experimental: Sub-Study D<br>Patients receive PET/CT scan on Vereos 128 digital PET/CT | Diagnostic Test: PET/CT scan with 13 mCi radiation dose<br>* 13 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT scan with 5 mCi radiation dose<br>* 5 mCi 18F-FDG dose<br>|
| Experimental: Sub-Study E<br>Patients receive lower radiation dose on Vereos 128 digital PET/CT | Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose<br>* 2.5 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose<br>* 6.5 mCi 18F-FDG dose<br>|
| Experimental: Sub-Study F<br>Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C | Diagnostic Test: PET/CT scan with 13 mCi radiation dose<br>* 13 mCi 18F-FDG dose<br>Diagnostic Test: PET/CT Scan with not yet determined radiation dose<br>* We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | assessed by blinded readers | through study completion, on average 2-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Artifacts | assessed by blinded readers | through study completion, on average 2-5 years | 
| Lesion detectability | assessed by blinded readers | through study completion, on average 2-5 years | 
| Image noise | assessed by blinded readers | through study completion, on average 2-5 years |