Clinical trial NCT03519659: Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Official title: Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PET/CT Imaging
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Ohio Third Frontier
First posted: 2018-05-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Image quality
timeFrame: through study completion, on average 2-5 years
Secondary outcomes:
measure: Artifacts
timeFrame: through study completion, on average 2-5 years
measure: Lesion detectability
timeFrame: through study completion, on average 2-5 years
measure: Image noise
timeFrame: through study completion, on average 2-5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael V Knopp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: