Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sub-Study A Patients receive PET/CT scan on Gemini Astonish PET/CT |
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
|
| Experimental: Sub-Study B Patients receive PET/CT scan on Biograph mCT |
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
|
| Experimental: Sub-Study C Patients receive PET/CT scan on Discovery PET/CT |
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
|
| Experimental: Sub-Study D Patients receive PET/CT scan on Vereos 128 digital PET/CT |
Diagnostic Test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic Test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
|
| Experimental: Sub-Study E Patients receive lower radiation dose on Vereos 128 digital PET/CT |
Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose
2.5 mCi 18F-FDG dose
Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose
6.5 mCi 18F-FDG dose
|
| Experimental: Sub-Study F 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
13 mCi 18F-FDG dose
Diagnostic Test: PET/CT Scan with not yet determined radiation dose
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.
|
Outcome Measures
Primary Outcome Measures
- Image quality [through study completion, on average 2-5 years]
assessed by blinded readers
Secondary Outcome Measures
- Artifacts [through study completion, on average 2-5 years]
assessed by blinded readers
- Lesion detectability [through study completion, on average 2-5 years]
assessed by blinded readers
- Image noise [through study completion, on average 2-5 years]
assessed by blinded readers
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43221 |
Sponsors and Collaborators
- Ohio State University
- National Cancer Institute (NCI)
- Ohio Third Frontier
Investigators
- Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University
Study Documents (Full-Text)
More Information
Publications
None provided.- RP0308/2014H0437
- R01CA195513