Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

April 8, 2021 updated by: Andrei Iagaru, Stanford University

Comparison of PET/CT vs. PET/MRI

This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

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
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University, School of Medicine

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

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  • Cancer diagnosis
  • Capable of complying with study procedures
  • Able to remain still for duration of imaging procedure (approximately 90 minutes total)
  • Written informed consent

EXCLUSION CRITERIA

  • Pregnant or nursing
  • Metallic implants
  • Impaired renal function

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FDG PET/CT Scan
Participants will undergo a PET/CT scan with radiolabel 18F-FDG.
Drug: F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
Experimental: 18F-FDG PET/MRI Scan
Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.
Drug: F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
Experimental: 68Ga-DOTA-TATE PET/CT Scan
Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
Drug: Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Experimental: 68Ga-DOTA-TATE PET/MRI Scan
Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
Drug: Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Time Frame: 4 hours
Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Time Frame: estimated average of 2 hours

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake within the region of interest (ROI). Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT and PET/MR.

Percentage difference is expressed as the difference of the means in SUVmax for the PET/CT and PET/MRI scan procedures for the particular radiotracer, divided by the mean between the values for the 2 scan procedures.

The closer the percent difference is to 0%, the better the agreement between the two scanners. The outcome is expressed as the percentage difference, a number without dispersion.
estimated average of 2 hours

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Andrei Iagaru, Stanford 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)

May 27, 2014

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

February 5, 2020

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-27398
  • NCI-2017-00364 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • VARIMG0004 (Other Identifier: OnCore)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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