Clinical trial NCT01133340: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: RADIOTHERAPY
CT simulation
MRI simulation
Endoscopic clip placement
Rectal cancer
Accuracy of MRI Simulation for target delineation and planning
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: IGAR Image guided adaptive radiotherapy
First posted: 2010-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images.
timeFrame: 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute, Alberta Health Services
name: Kurian Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: