The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

NCT ID: NCT01896713

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.

Detailed Description

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This is a prospective single arm study. 120 patients at risk for significant occult prostate cancer on an active surveillance program will undergo MS3TMRI followed by a standard TRUSBx and additional biopsies guided by the MS3TMRI results. The positive predictive value (PPV) of MS3TMRI-TRUSBx for cancer requiring consideration of therapy will be compared to the PPV of TRUSBx alone. MS3TMRI consists of T2, diffusion-weighted imaging (DWI), dynamic contrast enhanced MRI (DCEMRI), proton MR spectroscopy (MRS) interpreted by a radiologist and by CAD methods validated on whole mount prostate specimens.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic: Single Arm

Imaging (MS3TMRI)

Group Type OTHER

MS3TMRI

Intervention Type OTHER

Multispectral 3 Tesla MRI imaging with contrast followed by biopsy

Interventions

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MS3TMRI

Multispectral 3 Tesla MRI imaging with contrast followed by biopsy

Intervention Type OTHER

Other Intervention Names

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Multispectral 3 Tesla MRI imaging

Eligibility Criteria

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Inclusion Criteria

* Enrolled in active surveillance at Sunnybrook Health Sciences Centre, requiring biopsy as part of surveillance protocol.
* Clinically eligible for radical prostatectomy and willing to undergo surgery
* Clinically eligible for and willing to undergo ultrasound biopsy within 8 weeks of MRI

Exclusion Criteria

* Claustrophobia
* Contraindication to MRI
* Contraindication to receiving low molecular weight MRI contrast agent
* Prior hormone therapy except 5-alpha reductase inhibitors such as Avodart. FloMax etc
* Clinically suspected or known compromised renal function or calculated estimated Glomerular Filtration Rate (eGFR) \<30ml/min
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Masoom Haider

Chief, Department of Medical Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masoom Haider, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, University of Toronto

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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154-2009

Identifier Type: -

Identifier Source: org_study_id

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