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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:July 21, 2015
End Date:December 31, 2022
Contact:Melanie Hughes
Email:office@wcibmi.org
Phone:614-293-9998

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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.

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.

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
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
from
Columbus, OH
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