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Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
MRI
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Previously have had radical radiotherapy for localised prostate cancer Due to undergo routine post-treatment prostatic biopsies Suitable for MRI scan Adequate renal function No previous reaction to gadolinium Able to give informed consent No recent prostate biopsy within 6 weeks of enrolment Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1 Exclusion Criteria: Not suitable for MRI scan Previous reaction to gadolinium Impaired renal function Inability to give informed consent

Sites / Locations

  • University Health Network Princess Margaret Hospital

Outcomes

Primary Outcome Measures

To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy

Secondary Outcome Measures

Full Information

First Posted
September 28, 2005
Last Updated
July 10, 2009
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00230386
Brief Title
Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma
Official Title
The Role of MRI Perfusion to Detect Locally Recurrent or Persistent Disease in Prostate Carcinoma Treated With Radiation Therapy - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

Brief Summary
This is a pilot study of 50 patients to establish whether there is a potential role for MRI perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. All subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. The objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on MRI at these sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
To determine whether there may be a role for MRI perfusion in the detection of recurrent or persistent prostatic cancer after previous radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously have had radical radiotherapy for localised prostate cancer Due to undergo routine post-treatment prostatic biopsies Suitable for MRI scan Adequate renal function No previous reaction to gadolinium Able to give informed consent No recent prostate biopsy within 6 weeks of enrolment Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1 Exclusion Criteria: Not suitable for MRI scan Previous reaction to gadolinium Impaired renal function Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Role of Magnetic Resonance Imaging (MRI) Perfusion to Detect Disease in Prostate Carcinoma

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