Comparison of Whole Body DWI to FDG PET

NCT ID: NCT06630845

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fluorodeoxyglucose F18

Intervention Type DRUG

Given IV as part of routine imaging

Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)

Intervention Type PROCEDURE

Imaging procedure

Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)

Intervention Type PROCEDURE

Imaging procedure done concurrently with PET/MRI

General Electric (GE) SIGNA PET/MR

Intervention Type DEVICE

Imaging device

Interventions

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Fluorodeoxyglucose F18

Given IV as part of routine imaging

Intervention Type DRUG

Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)

Imaging procedure

Intervention Type PROCEDURE

Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)

Imaging procedure done concurrently with PET/MRI

Intervention Type PROCEDURE

General Electric (GE) SIGNA PET/MR

Imaging device

Intervention Type DEVICE

Other Intervention Names

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Fludeoxyglucose F18 (FDG) 2-deoxy-2-[fluorine-18]fluoro-D-glucose Fluorodeoxyglucose PET/MRI WB-MRI-DWI GE SIGNA PET/MR SIGNA PET/MR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Abdominal Radiology

OTHER

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas A Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brad Kline

Role: CONTACT

877-827-3222

Facility Contacts

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Brad Kline

Role: primary

Role: backup

877-827-3222

Other Identifiers

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NCI-2024-09278

Identifier Type: REGISTRY

Identifier Source: secondary_id

24926

Identifier Type: -

Identifier Source: org_study_id

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