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 Alberta10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

RadiationRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.