Endorectal Coil Magnetic Resonance Images (ERC-MRI)

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00160953
• Collaborator: Abbott (Industry), Canadian Association of Radiation Oncology (Industry), Uro-Oncologic Radiation Award (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Procedure: Endorectal Coil Magnetic Resonance Images	Phase 2

Study Design

• Study Type: Interventional
• 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: Feb 1, 2005
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00160953
• Other Study ID Numbers: UHN REB 05-0041-C
• First Posted: Sep 12, 2005
• Last Update Posted: Aug 11, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Aug 11, 2010