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

NCT ID: NCT01133340

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed Description

1. 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.

2. 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.

3. 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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Radiation

No treatment intervention is planned. Patients will be scanned and treated as per department standards. The patient will have MRI at the time of their standard plan. They will then have clips inserted to mark the tumor after the standard scan is performed. The MRI and additional imaging with clips in place will be processed by 3 investigators who will contour based on the experimental image and compare this with the standard treated plan. Comparison of volumes in a blinded manner between investigators will also occur. The patients treatment will not be affected by the MRI or clip placement.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGAR Image guided adaptive radiotherapy

UNKNOWN

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurian Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute, Alberta Health Services

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

RECTAL MRI SIM 25409

Identifier Type: -

Identifier Source: org_study_id