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Trial Title:
Comparison of Whole Body DWI to FDG PET
NCT ID:
NCT06630845
Condition:
Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Fluorodeoxyglucose F18
Conditions: Keywords:
Imaging Study
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluorodeoxyglucose F18
Description:
Given IV as part of routine imaging
Arm group label:
Whole Body DWI plus FDG PET/MRI
Other name:
Fludeoxyglucose F18 (FDG)
Other name:
2-deoxy-2-[fluorine-18]fluoro-D-glucose
Other name:
Fluorodeoxyglucose
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)
Description:
Imaging procedure
Arm group label:
Whole Body DWI plus FDG PET/MRI
Other name:
PET/MRI
Intervention type:
Procedure
Intervention name:
Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)
Description:
Imaging procedure done concurrently with PET/MRI
Arm group label:
Whole Body DWI plus FDG PET/MRI
Other name:
WB-MRI-DWI
Intervention type:
Device
Intervention name:
General Electric (GE) SIGNA PET/MR
Description:
Imaging device
Arm group label:
Whole Body DWI plus FDG PET/MRI
Other name:
GE SIGNA PET/MR
Other name:
SIGNA PET/MR
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Brad Kline
Email:
Brad.Kline@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Thomas Hope, MD
Email:
Principal Investigator
Start date:
November 30, 2024
Completion date:
July 31, 2029
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Society of Abdominal Radiology
Agency class:
Other
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630845
