Prostate Cancer Clinical Trial
Official title:
Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
NCT number | NCT03440554 |
Other study ID # | 151686 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 24, 2016 |
Est. completion date | January 1, 2023 |
This study aims to learn how to improve MRIs (Magnetic Resonance Imaging) that do not require the patient to be injected with a contrast dye. Researchers expect to learn how to better find and describe tumors in patients with prostate cancer. Participants have a whole body research MRI scan within 90 days of a standard-of-care imaging procedure. The research study will collect copies of those scans to compare to the research scans as part of the study analysis. Patients who have additional standard-of-care scans within 12 months after their research scan may be asked to have a second non-contrast MRI for research within 90 days of their follow-up standard of care imaging. The whole body MRI scan will be compared to the standard-of-care scan for prostate cancer detection and to assess patient response to standard-of-care treatment.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2023 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have known or suspected genitourinary metastatic disease and have already had or will have a CT, PET/CT, bone scan or MRI with contrast. - Age = 18 years. - ECOG performance status 0-3. - Capacity to give informed consent. - Ability to lay supine for 30-60 minutes - Ability to hear adequately without hearing aids. Exclusion Criteria: - Patients with medical implants/devices or indwelling foreign material considered unsafe for MRI scanning will be excluded. Safety of medical implants/devices will be determined by the current UC San Diego Radiology and Imaging Services MRI safety policy. The name, manufacturer, and model number of any medical implant/device contained within a potential study subject will be obtained and reviewed to determine safety. Patients will be excluded if any implant/device is found to be unsafe for MRI scanning. - Patients may be excluded if their weight exceeds 350 lbs, the limit for the safe operation of the MRI scanning table. - A patient who is pregnant or trying to become pregnant will be excluded. - Patients with any other condition that, in the opinion of the investigator, may deem them ineligible for study participation. |
Country | Name | City | State |
---|---|---|---|
United States | UC San Diego Moores Cancer Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Prostate Cancer Foundation, United States Department of Defense |
United States,
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Rakow-Penner RA, White NS, Parsons JK, Choi HW, Liss MA, Kuperman JM, Schenker-Ahmed N, Bartsch H, Mattrey RF, Bradley WG, Shabaik A, Huang J, Margolis DJ, Raman SS, Marks L, Kane CJ, Reiter RE, Karow DS, Dale AM. Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. Prostate Cancer Prostatic Dis. 2015 Mar;18(1):81-5. doi: 10.1038/pcan.2014.50. Epub 2015 Jan 6. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging | Paired t-test | 15 months | |
Primary | Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV) | For each identified lesion in the PET/CT, the lesion will be outlined, the size measured in millimeters, and the SUV will be calculated using the following equation: SUV= (decay-(corrected activity (kBq))/(tissue volume (ml) ))/(injected=(FDG activity (kBq))/(body weight (g) )) Baseline SUVs will also be calculated within normal appearing tissue. Similarly, for each identified lesion in the whole-body RSI-MRI, the lesion will be outlined, the size measured as indicated above, and the CI will be calculated. Baseline CIs will also be calculated within normal appearing tissue. The quantitative data will be analyzed for correlation across all lesions in all patients to determine the degree to which PET/CT SUV values and RSI-MRI CI values co-vary. Significance of the correlation coefficient, compared to zero correlation, will be assessed via the Student t-test, with alpha set to 0.05. |
15 months |
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