Status:
COMPLETED
Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Rectal Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to see whether three new types of MRI techniques used during magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to tell if the tumor ...
Detailed Description
This is a pilot study of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI, aka perfusion MRI) and diffusion-weighted MRI (DWI-MRI), herein referred to in combination as advanced MRI (aMRI...
Eligibility Criteria
Inclusion
- Patients with primary locally advanced rectal adenocarcinoma (0-18cm from the anal verge) confirmed by MSKCC pathologist and eligible to undergo chemoradiation and surgical resection at MSKCC.
- Written informed consent
- Age equal to or greater than 21 years
- Willing and able to undergo all study procedures
- Patients must have a planned surgical resection of the rectum
Exclusion
- Patients younger than 21 years
- Pregnant and nursing women
- Contraindications for MRI (such as claustrophobia, pacemaker, non MR-compatible artificial heart valves, cochlear implants, surgical clips in the brain, metal fragments in eye)
- Estimated GFR (using Cockcroft formula Appendix 2) less than 30 ml/min/1.73m2 (FDA advises caution in using gadolinium-based contrast agents in patients with severe renal impairment).
- History of allergic reaction to MR contrast media
- Inability to give informed consent in person
Key Trial Info
Start Date :
April 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01830582
Start Date
April 9 2013
End Date
June 20 2017
Last Update
June 22 2017
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065