Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Prostate Cancer

Treatments: Other: MRI with gadofosveset and MR elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT01761812

334-2011

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy

Exclusion criteria

• unable to give informed consent
• contraindication to MRI or MRI contrast agent
• claustrophobia
• renal impairment
• prior hormonal or radiation therapy for prostate cancer
• active prostatitis
• moderate to severe rectal inflammation
• previous rectal surgery
• prostate biopsy within 4 weeks of planned MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single arm study

Experimental group

Treatment:

Other: MRI with gadofosveset and MR elastography