Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

NCT01761812 | Terminated

• 1 other identifier: 334-2011
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; MRI; Elastography; Gadofosveset

Outcome Measures

Primary Outcomes (2)

• Correlation coefficient

  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.

  This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).

• Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method

  This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).

Study Arms (1)

Single arm study

EXPERIMENTAL

Other: MRI with gadofosveset and MR elastography

Interventions

MRI with gadofosveset and MR elastography OTHER

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; gadofosveset trisodium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Masoom A Haider, M.D.

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Radiologist

Study Record Dates

• First Submitted: January 1, 2013
• First Posted: January 7, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

CA (1)