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Clinical Trials/NCT01133340
NCT01133340
Completed
Not Applicable

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

AHS Cancer Control Alberta1 site in 1 country10 target enrollmentJune 2010
ConditionsRectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Cancer
Sponsor
AHS Cancer Control Alberta
Enrollment
10
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
November 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images.(1 year)

Study Sites (1)

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