Comparison of Whole Body DWI to FDG PET

March 30, 2026 updated by: University of California, San Francisco

Comparison of Whole Body DWI to FDG PET Using PET/MRI

This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Correlation of DWI and FDG to detect disease.

SECONDARY OBJECTIVE:

I. Inter-reader variability of DWI interpretation by region.

OUTLINE:

Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Thomas Hope, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
  3. Ability to understand a written informed consent document, and the willingness to sign it.
  4. Diagnosis of metastatic cancer.

Exclusion Criteria:

  1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  2. Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Body DWI plus FDG PET/MRI
Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.
Drug: Fluorodeoxyglucose F18
Given IV as part of routine imaging
Other Names:
  • Fluorodeoxyglucose
  • Fludeoxyglucose F18 (FDG)
  • 2-deoxy-2-[fluorine-18]fluoro-D-glucose
Procedure: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)
Imaging procedure
Other Names:
  • PET/MRI
Procedure: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)
Imaging procedure done concurrently with PET/MRI
Other Names:
  • WB-MRI-DWI
Device: General Electric (GE) SIGNA PET/MR
Imaging device
Other Names:
  • GE SIGNA PET/MR
  • SIGNA PET/MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of lesions characterized as positive
Time Frame: Up to 6 months
The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-reader variability of diffusion weight imaging (DWI) interpretation
Time Frame: Up to 6 months
Inter-reader variability is the degree of agreement among independent observers who rate, code, or assess the same image. Eighteen regions per participant will be scored by two blinded readers at each time point and assessed for the presence of DWI positive disease (local disease; nodal disease: pelvic, retroperitoneal, thoracic, and other; osseous disease: skull, ribs and sternum, cervical/thoracic/lumbar spine, right/left pelvis, sacrum and upper/lower extremities; visceral disease: lung, liver, and other). Scores range from 0 to 1 with 1 being excellent agreement between the two readers.
Up to 6 months

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

GE Healthcare
Society of Abdominal Radiology

Investigators

  • Principal Investigator: Thomas A Hope, MD, University of California, San Francisco

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)

February 6, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24926 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • NCI-2024-09278 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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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