Endorectal Coil Magnetic Resonance Images (ERC-MRI) | NCT00160953

Studies
Endorectal Coil Magnetic Resonance Images (ERC-MRI)

NCT00160953

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Aug 11, 2010Estimated

Enrollment

Phase

Phase 2

Conditions

Prostatic Neoplasms

Interventions

Endorectal Coil Magnetic Resonance Images

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2010

Last Update Posted Date

Aug 11, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Health Network, TorontoOTHER

Collaborators

Name	Class
Abbott	INDUSTRY
Canadian Association of Radiation Oncology	INDUSTRY
Uro-Oncologic Radiation Award	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Endorectal Coil Magnetic Resonance Images	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Menard Cynthia, MD	Princess Margaret Hospital, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Hospital		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided