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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-09278 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Society of Abdominal Radiology | OTHER |
| GE Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Body DWI plus FDG PET/MRI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorodeoxyglucose F18 | Drug | Given IV as part of routine imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-reader variability of diffusion weight imaging (DWI) interpretation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brad Kline | Contact | 877-827-3222 | brad.kline@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas A Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) | Procedure | Imaging procedure |
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| Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) | Procedure | Imaging procedure done concurrently with PET/MRI |
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| General Electric (GE) SIGNA PET/MR | Device | Imaging device |
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| Up to 6 months |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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