Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatment advanced mr imaging
Sponsor Memorial Sloan Kettering Cancer Center
Start date April 2013
End date April 2017
Trial size 28 participants
Trial identifier NCT01830582, 13-019

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 is getting better in response to the radiation and/or chemotherapy treatments.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
The patients will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 24 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the second week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
advanced mr imaging
(Experimental)
The patient will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 48 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the third week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
advanced mr imaging
(Experimental)
The patient will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 72 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the fourth week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
advanced mr imaging
(Experimental)
The last patient patients that will undergo a standard pre-chemoradiation MRI scan, followed by a repeat research scan either 24, 48 or 72 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the second, third or fourth week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
advanced mr imaging

Primary Outcomes

Measure
determine the best MR imaging schedule
time frame: 3 years

Secondary Outcomes

Measure
Determine if the best imaging schedule for DCE is the same as for DWI
time frame: 3 years

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Pilot Study of Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
Principal investigator Marc J. Gollub, MD
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) in the investigation of early tumor response to standard multi-dose, fractionated external beam radiotherapy (EBRT) of the pelvis given in the neoadjuvant setting concurrent with chemotherapy as well as induction chemotherapy prior to chemoradiotherapy or consolidation chemotherapy after chemoradiotherapy for primary rectal adenocarcinoma. This protocol aims to expand upon the growing body of knowledge concerning early changes in tumor neovascularity and cellular density as a potential biomarker of therapy efficacy. It further aims to address the trend towards more refined treatment stratification for lower risk tumors to avoid morbidity from potentially unnecessary radiation, chemotherapy or even radical surgery, by assessing the earliest changes that occur in microvasculature and perfusion and diffusion of water during this treatment to see if these can be predictive of long-term efficacy of therapy.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in August 2016.