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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

Primary Purpose

Rectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Radiation

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring RADIOTHERAPY, CT simulation, MRI simulation, Endoscopic clip placement, Rectal cancer, Accuracy of MRI Simulation for target delineation and planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cross Cancer Institute

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images.

Full Information

NCT ID

NCT01133340

First Posted

May 27, 2010

Last Updated

October 1, 2014

Sponsor

AHS Cancer Control Alberta

Collaborators

IGAR Image guided adaptive radiotherapy

1. Study Identification

Unique Protocol Identification Number

NCT01133340

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

IGAR Image guided adaptive radiotherapy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

RADIOTHERAPY, CT simulation, MRI simulation, Endoscopic clip placement, Rectal cancer, Accuracy of MRI Simulation for target delineation and planning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kurian Joseph, MD

Organizational Affiliation

Cross Cancer Institute, Alberta Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

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