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

University of Cincinnati

Status: Active, not recruiting

Conditions: PET/CT Imaging

Treatments: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose; Diagnostic Test: PET/CT scan with 5 mCi radiation dose; Diagnostic Test: PET/CT Scan with not yet determined radiation dose; Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03519659

R01CA195513 (U.S. NIH Grant/Contract)

RP0308/2014H0437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 6 patient groups

Sub-Study A

Experimental group

Description:

Patients receive PET/CT scan on Gemini Astonish PET/CT

Treatment:

Diagnostic Test: PET/CT scan with 5 mCi radiation dose

Diagnostic Test: PET/CT scan with 13 mCi radiation dose

Sub-Study B

Experimental group

Description:

Patients receive PET/CT scan on Biograph mCT

Treatment:

Diagnostic Test: PET/CT scan with 5 mCi radiation dose

Diagnostic Test: PET/CT scan with 13 mCi radiation dose

Sub-Study C

Experimental group

Description:

Patients receive PET/CT scan on Discovery PET/CT

Treatment:

Diagnostic Test: PET/CT scan with 5 mCi radiation dose

Diagnostic Test: PET/CT scan with 13 mCi radiation dose

Sub-Study D

Experimental group

Description:

Patients receive PET/CT scan on Vereos 128 digital PET/CT

Treatment:

Diagnostic Test: PET/CT scan with 5 mCi radiation dose

Diagnostic Test: PET/CT scan with 13 mCi radiation dose

Sub-Study E

Experimental group

Description:

Patients receive lower radiation dose on Vereos 128 digital PET/CT

Treatment:

Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose

Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose

Sub-Study F

Experimental group

Description:

Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C

Treatment:

Diagnostic Test: PET/CT Scan with not yet determined radiation dose

Diagnostic Test: PET/CT scan with 13 mCi radiation dose