NCT03519659

Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PET/CT Imaging

Interventions

Type	Name	Description
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
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
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.

Timeline

• Start date: 2015-07-21
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-05-09
• Last updated: 2024-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study