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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
190
13 mCi 18F-FDG dose
5 mCi 18F-FDG dose
2.5 mCi 18F-FDG dose
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Image quality
assessed by blinded readers
Time frame: through study completion, on average 2-5 years
Artifacts
assessed by blinded readers
Time frame: through study completion, on average 2-5 years
Lesion detectability
assessed by blinded readers
Time frame: through study completion, on average 2-5 years
Image noise
assessed by blinded readers
Time frame: through study completion, on average 2-5 years
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6.5 mCi 18F-FDG 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.