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

PET/CT Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519659
• Other study ID #: RP0308/2014H0437
• Secondary ID: R01CA195513
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PET/CT Imaging

Intervention

Diagnostic Test:
• PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
• PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
• PET/CT scan with 2.5 mCi radiation dose
2.5 mCi 18F-FDG dose
• PET/CT Scan with 6.5 mCi radiation dose
6.5 mCi 18F-FDG dose
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	National Cancer Institute (NCI), Ohio Third Frontier

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality	assessed by blinded readers	through study completion, on average 2-5 years
Secondary	Artifacts	assessed by blinded readers	through study completion, on average 2-5 years
Secondary	Lesion detectability	assessed by blinded readers	through study completion, on average 2-5 years
Secondary	Image noise	assessed by blinded readers	through study completion, on average 2-5 years