Endorectal Coil Magnetic Resonance Images (ERC-MRI)

August 10, 2010 updated by: University Health Network, Toronto

Development of a Prostate Deformation Model to Enable Accurate Registration of Endorectal Coil Magnetic Resonance Images (ERC-MRI) to Reference Treatment Planning CT Images

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Menard Cynthia, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • UHN REB 05-0041-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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