PET/CT Imaging
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTPET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
DIAGNOSTIC_TESTPET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
DIAGNOSTIC_TESTPET/CT scan with 2.5 mCi radiation dose
2.5 mCi 18F-FDG dose
DIAGNOSTIC_TESTPET/CT Scan with 6.5 mCi radiation dose
6.5 mCi 18F-FDG dose
DIAGNOSTIC_TESTPET/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.
Sponsors
National Cancer Institute (NCI)
Ohio Third Frontier
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality | through study completion, on average 2-5 years | assessed by blinded readers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image noise | through study completion, on average 2-5 years | assessed by blinded readers |
| 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 |
Countries
United States
Outcome results
None listed