Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
- Conditions
- PET/CT Imaging
- Interventions
- Diagnostic Test: PET/CT scan with 13 mCi radiation doseDiagnostic Test: PET/CT scan with 2.5 mCi radiation doseDiagnostic Test: PET/CT scan with 5 mCi radiation doseDiagnostic Test: PET/CT Scan with 6.5 mCi radiation doseDiagnostic Test: PET/CT Scan with not yet determined radiation dose
- Registration Number
- NCT03519659
- Lead Sponsor
- University of Cincinnati
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sub-Study F PET/CT scan with 13 mCi radiation dose Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C Sub-Study B PET/CT scan with 13 mCi radiation dose Patients receive PET/CT scan on Biograph mCT Sub-Study C PET/CT scan with 13 mCi radiation dose Patients receive PET/CT scan on Discovery PET/CT Sub-Study D PET/CT scan with 5 mCi radiation dose Patients receive PET/CT scan on Vereos 128 digital PET/CT Sub-Study E PET/CT Scan with 6.5 mCi radiation dose Patients receive lower radiation dose on Vereos 128 digital PET/CT Sub-Study A PET/CT scan with 13 mCi radiation dose Patients receive PET/CT scan on Gemini Astonish PET/CT Sub-Study A PET/CT scan with 5 mCi radiation dose Patients receive PET/CT scan on Gemini Astonish PET/CT Sub-Study F PET/CT Scan with not yet determined radiation dose Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C Sub-Study C PET/CT scan with 5 mCi radiation dose Patients receive PET/CT scan on Discovery PET/CT Sub-Study B PET/CT scan with 5 mCi radiation dose Patients receive PET/CT scan on Biograph mCT Sub-Study D PET/CT scan with 13 mCi radiation dose Patients receive PET/CT scan on Vereos 128 digital PET/CT Sub-Study E PET/CT scan with 2.5 mCi radiation dose Patients receive lower radiation dose on Vereos 128 digital PET/CT
- Primary Outcome Measures
Name Time Method Image quality through study completion, on average 2-5 years assessed by blinded readers
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States