Comparison of Whole Body DWI to FDG PET
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
March 20, 2025
March 1, 2025
2.7 years
October 4, 2024
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of lesions characterized as positive
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 Outcomes (1)
Inter-reader variability of diffusion weight imaging (DWI) interpretation
Up to 6 months
Study Arms (1)
Whole Body DWI plus FDG PET/MRI
EXPERIMENTALParticipants 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.
Interventions
Given IV as part of routine imaging
Imaging procedure
Imaging procedure done concurrently with PET/MRI
Imaging device
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of metastatic cancer.
You may not qualify if:
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Society of Abdominal Radiologycollaborator
- GE Healthcarecollaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A Hope, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 8, 2024
Study Start
February 6, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2029
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share