Multiparametric MRI for Prostate Cancer Localization and... | NCT01761812

Studies
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

NCT01761812

Sponsor

Sunnybrook Health Sciences Centre

Status

Terminated

Last Update Posted

Oct 18, 2016Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

MRI with gadofosveset and MR elastography

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate accrual

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 1, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Masoom Haider, Staff Radiologist, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm study	Experimental		Other: MRI with gadofosveset and MR elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI with gadofosveset and MR elastography	Other		Single arm study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masoom A Haider, M.D.	Sunnybrook Health Sciences Centre, University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy
C109932	gadofosveset trisodium

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided