A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation

October 1, 2014 updated by: AHS Cancer Control Alberta

This study is looking for a better way to define rectal tumors undergoing pre-operative radiation. MRI scanning generally results in more clear definition of the tumor that CT scanning. Insertion of radio opaque clips in the tumor site could also help to visualize the tumor better for radiotherapy treatment planning. The investigators believe both techniques would help the physician to define to cancer better than using CT scan alone. The investigators also will compare both techniques to define the better way to define the tumor.

Study Overview

Status

Completed

Conditions

Rectal Cancer

Intervention / Treatment

Radiation: Radiation

Detailed Description

The use of endoscopically placed mucosal metal clips to define the superior and inferior extent of the rectal tumor will improve the accuracy of tumor localization in patients undergoing non-contrast CT simulation.
A 3T-MRI will provide a better localization of the rectal tumor and pelvic nodes compared to non-contrast CT simulation for radiotherapy treatment planning.
By comparing these two novel methods to the standard procedure, we would be able to define any difference between the three methods and obtain an estimate of the accuracy and reliability of each method for the localization of the rectal tumor.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with adenocarcinoma of the rectum stage as T3/4 N0/1/2 M0 undergoing pre-operative chemoradiation
Patients must be 18 years of age or greater
Signed study-specific informed consent
Not pregnant or lactating

Exclusion Criteria:

Contraindication for radiotherapy or chemoradiation
Contraindication for MRI scanning
Prior chemotherapy or radiation therapy to the pelvis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To define the usefulness of Endoscopic clip placement and 3T-MRI imaging for accurate target volume definition in rectal cancer patients undergoing pre-operative chemoradiation. Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images. Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

IGAR Image guided adaptive radiotherapy

Investigators

Principal Investigator: Kurian Joseph, MD, Cross Cancer Institute, Alberta Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)