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Endorectal Coil Magnetic Resonance Images (ERC-MRI)

This study has been completed.
Sponsor:
Collaborators:
Abbott
Canadian Association of Radiation Oncology
Uro-Oncologic Radiation Award
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00160953
First received: September 8, 2005
Last updated: August 10, 2010
Last verified: August 2010
History of Changes

September 8, 2005
August 10, 2010
February 2005
February 2010   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00160953 on ClinicalTrials.gov Archive Site
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Endorectal Coil Magnetic Resonance Images (ERC-MRI)
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.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostatic Neoplasms
Procedure: Endorectal Coil Magnetic Resonance Images
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00160953
UHN REB 05-0041-C
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University Health Network, Toronto
  • Abbott
  • Canadian Association of Radiation Oncology
  • Uro-Oncologic Radiation Award
Principal Investigator: Menard Cynthia, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP