Comparison of Whole Body DWI to FDG PET

Not Applicable

Recruiting

• Conditions: Metastatic Cancer
• Interventions: Drug: Fluorodeoxyglucose F18; Procedure: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI); Procedure: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI); Device: General Electric (GE) SIGNA PET/MR

• Registration Number: NCT06630845
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Study Start: 2025-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-10-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Whole Body DWI plus FDG PET/MRI	Fluorodeoxyglucose F18	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.
Whole Body DWI plus FDG PET/MRI	Positron Emission Tomography combined with Magnetic resonance imaging (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.
Whole Body DWI plus FDG PET/MRI	Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)	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.
Whole Body DWI plus FDG PET/MRI	General Electric (GE) SIGNA PET/MR	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.

Primary Outcome Measures

Name	Time	Method
Proportion of lesions characterized as positive	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.

Secondary Outcome Measures

Name	Time	Method
Inter-reader variability of diffusion weight imaging (DWI) interpretation	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States