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Endorectal Coil Magnetic Resonance Images (ERC-MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160953
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 11, 2010
Sponsor:
Collaborators:
Abbott
Canadian Association of Radiation Oncology
Uro-Oncologic Radiation Award
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Endorectal Coil Magnetic Resonance Images Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : February 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160953


Locations
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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Abbott
Canadian Association of Radiation Oncology
Uro-Oncologic Radiation Award
Investigators
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Principal Investigator: Menard Cynthia, MD Princess Margaret Hospital, Canada
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ClinicalTrials.gov Identifier: NCT00160953    
Other Study ID Numbers: UHN REB 05-0041-C
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases