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Endorectal Coil Magnetic Resonance Images (ERC-MRI)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Endorectal Coil Magnetic Resonance Images
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatic Neoplasms

Eligibility Criteria

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

Inclusion Criteria: adenocarcinoma of the prostate patient undergoing dose escalated conformal EBRT low or intermediate risk prognostic factors: PSA < or equa to20, gleason score <8, T <T3, N category 0 or X, M category 0 or X > or equal to 18 years of age ECOG performance status 0 or 1 Exclusion Criteria: contraindications to MRI bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding insertion of fiducial markers IFB or collagen vascular disease previous colorectal surgery previous pelvic RT

Sites / Locations

  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

The primary aim of this study is to develop a prostate deformation model using the finite element method from anatomic MR images of the prostate gland acquired with and without ERC.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
August 10, 2010
Sponsor
University Health Network, Toronto
Collaborators
Abbott, Canadian Association of Radiation Oncology, Uro-Oncologic Radiation Award
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1. Study Identification

Unique Protocol Identification Number
NCT00160953
Brief Title
Endorectal Coil Magnetic Resonance Images (ERC-MRI)
Official Title
Development of a Prostate Deformation Model to Enable Accurate Registration of Endorectal Coil Magnetic Resonance Images (ERC-MRI) to Reference Treatment Planning CT Images
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Abbott, Canadian Association of Radiation Oncology, Uro-Oncologic Radiation Award

4. Oversight

5. Study Description

Brief Summary
When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the rectum, we can see areas with tumour in the prostate gland, and well as details of the anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use this images to help target radiation therapy to the tumour better, we need to deform the images to the original shape of the prostate gland without the coil. In this study, we will develop a way to deform the images accurately.

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
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Endorectal Coil Magnetic Resonance Images
Primary Outcome Measure Information:
Title
The primary aim of this study is to develop a prostate deformation model using the finite element method from anatomic MR images of the prostate gland acquired with and without ERC.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adenocarcinoma of the prostate patient undergoing dose escalated conformal EBRT low or intermediate risk prognostic factors: PSA < or equa to20, gleason score <8, T <T3, N category 0 or X, M category 0 or X > or equal to 18 years of age ECOG performance status 0 or 1 Exclusion Criteria: contraindications to MRI bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding insertion of fiducial markers IFB or collagen vascular disease previous colorectal surgery previous pelvic RT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menard Cynthia, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Endorectal Coil Magnetic Resonance Images (ERC-MRI)

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