Endorectal Coil Magnetic Resonance Images (ERC-MRI)

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160953
• Other study ID #: UHN REB 05-0041-C
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: August 10, 2010
• Start date: February 2005
• Est. completion date: February 2010

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• Endorectal Coil Magnetic Resonance Images

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Abbott, Canadian Association of Radiation Oncology, Uro-Oncologic Radiation Award

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.