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

NCT03519659 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-01-18

No results posted yet for this study

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.

Conditions

  • PET/CT Imaging

Interventions

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

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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio Third Frontier

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Michael V Knopp, MD, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-21
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519659 on ClinicalTrials.gov