Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
June 21, 2017 updated by: Memorial Sloan Kettering Cancer Center
Pilot Study of Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
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.
Study Overview
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) 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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1 A
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.
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Experimental: 1 B
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.
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Experimental: 1 C
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.
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Experimental: 2
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determine the best MR imaging schedule
Time Frame: 3 years
|
of early and midterm imaging times using DWI-MRI which will distinguish between near complete (90-99%)/complete pathology and clinical responders and partial/non-responders
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine if the best imaging schedule for DCE is the same as for DWI
Time Frame: 3 years
|
The analysis plan will be identical to the one for the primary endpoint: six change measures will be computed for each DCE-MRI parameter (parameters Ktrans, Ve, kep, AUC 90, AUC 180) and each of these change measures will be evaluated as a predictor using the reference standard nCR/CR.
ROC curves and the area under them will be estimated and used to rank the predictors.
|
3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc J. Gollub, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2013
Primary Completion (Actual)
June 20, 2017
Study Completion (Actual)
June 20, 2017
Study Registration Dates
First Submitted
April 10, 2013
First Submitted That Met QC Criteria
April 10, 2013
First Posted (Estimate)
April 12, 2013
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-019
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