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

Not Applicable
Active, not recruiting
Conditions
PET/CT Imaging
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Image qualitythrough study completion, on average 2-5 years

assessed by blinded readers

Secondary Outcome Measures
NameTimeMethod
Artifactsthrough study completion, on average 2-5 years

assessed by blinded readers

Lesion detectabilitythrough study completion, on average 2-5 years

assessed by blinded readers

Image noisethrough 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

The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States

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