Metastatic Cancer
Conditions
Keywords
Imaging Study
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.
Interventions
DRUGFluorodeoxyglucose F18
Given IV as part of routine imaging
PROCEDUREPositron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)
Imaging procedure
PROCEDUREWhole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)
Imaging procedure done concurrently with PET/MRI
DEVICEGeneral Electric (GE) SIGNA PET/MR
Imaging device
Sponsors
University of California, San Francisco
Society of Abdominal Radiology
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTBrad Kline
PRINCIPAL_INVESTIGATORThomas A Hope, MD
University of California, San Francisco
Outcome results
None listed