Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
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|ClinicalTrials.gov Identifier: NCT03440554|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : October 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Diagnostic Test: Whole Body Non-Contrast MRI||Not Applicable|
Participants will undergo a whole body non-contrast MRI study with a whole-body protocol incorporating routine clinical sequences as well as non-contrast research sequences. The patient will also undergo clinically indicated standard-of-care imaging such as PET/CT, CT, Technetium-99m bone scan or MRI with contrast as determined by the patient's oncologist. When the standard-of-care imaging has not yet been performed upon enrollment, the research MRI will ideally be performed on the same day as the standard-of-care exam. However, scheduling constraints and patient time constraints may preclude scheduling both scans on the same day. In this case, the scans will be performed within a week 90 days of each other. An experienced radiologist will read both scans and results will be provided to the patient's oncologist for clinical follow up.
Patients receiving additional standard-of-care imaging within 12 months after the research MRI may be asked to return for an additional whole body MRI scan within 90 days of their standard-of-care scan. The additional research scan will be requested of patients that have evidence of progression during ongoing standard of care treatment and monitoring. The additional scan would be requested of those patients to compare baseline scans to those that are completed during standard of care imaging. This would be an additional tool to verify disease progression or treatment response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prostate cancer patients will have a research whole body MRI scan within 90 days of their standard of care imaging. Patients receiving additional standard of care imaging within 12 months of the research scan will be asked to have an additional research scan within 90 days of their follow-up imaging.|
|Masking:||None (Open Label)|
|Official Title:||Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization|
|Actual Study Start Date :||March 24, 2016|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
|Experimental: Whole Body Non-Contrast MRI||
Diagnostic Test: Whole Body Non-Contrast MRI
Whole Body Non-Contrast MRI in Prostate Cancer Patients
- Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging [ Time Frame: 15 months ]Paired t-test
- Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV) [ Time Frame: 15 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440554
|Contact: Candace Winkler, MSfirstname.lastname@example.org|
|Contact: Michael E Hahn, MD||(619)email@example.com|
|Principal Investigator:||Michael E Hahn, MD||UC San Diego Moores Cancer Center|