Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods
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ClinicalTrials.gov Identifier: NCT01761812
Recruitment Status :
The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.
Correlation coefficient [ Time Frame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment). ]
Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference.
Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method [ Time Frame: This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment). ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy
unable to give informed consent
contraindication to MRI or MRI contrast agent
prior hormonal or radiation therapy for prostate cancer