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

January 16, 2024 updated by: Michael V Knopp MD PhD, University of Cincinnati
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43221
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub-Study A
Patients receive PET/CT scan on Gemini Astonish PET/CT
Diagnostic test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
Experimental: Sub-Study B
Patients receive PET/CT scan on Biograph mCT
Diagnostic test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
Experimental: Sub-Study C
Patients receive PET/CT scan on Discovery PET/CT
Diagnostic test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
Experimental: Sub-Study D
Patients receive PET/CT scan on Vereos 128 digital PET/CT
Diagnostic test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic test: PET/CT scan with 5 mCi radiation dose
5 mCi 18F-FDG dose
Experimental: Sub-Study E
Patients receive lower radiation dose on Vereos 128 digital PET/CT
Diagnostic test: PET/CT scan with 2.5 mCi radiation dose
2.5 mCi 18F-FDG dose
Diagnostic test: PET/CT Scan with 6.5 mCi radiation dose
6.5 mCi 18F-FDG dose
Experimental: Sub-Study F
Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C
Diagnostic test: PET/CT scan with 13 mCi radiation dose
13 mCi 18F-FDG dose
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality
Time Frame: through study completion, on average 2-5 years
assessed by blinded readers
through study completion, on average 2-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artifacts
Time Frame: through study completion, on average 2-5 years
assessed by blinded readers
through study completion, on average 2-5 years
Lesion detectability
Time Frame: through study completion, on average 2-5 years
assessed by blinded readers
through study completion, on average 2-5 years
Image noise
Time Frame: through study completion, on average 2-5 years
assessed by blinded readers
through study completion, on average 2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Cancer Institute (NCI)
Ohio Third Frontier

Investigators

  • Principal Investigator: Michael V Knopp, MD, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2015

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RP0308/2014H0437
  • R01CA195513 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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