Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Cincinnati
- Enrollment
- 190
- Locations
- 2
- Primary Endpoint
- Image quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Image quality
Time Frame: through study completion, on average 2-5 years
assessed by blinded readers
Secondary Outcomes
- Artifacts(through study completion, on average 2-5 years)
- Lesion detectability(through study completion, on average 2-5 years)
- Image noise(through study completion, on average 2-5 years)
Investigators
Michael V Knopp MD PhD
Professor
University of Cincinnati