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Pilot Study of Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer

21 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

Pilot Study of Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer

This is a pilot study of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI, aka
perfusion MRI), diffusion-weighted MRI (DWI-MRI), and proton magnetic resonance spectroscopy
(MRS), 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 for primary
rectal adenocarcinoma. This protocol aims to expand upon the growing body of knowledge
concerning early changes in tumor neovascularity 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, perfusion and diffusion of water molecules and metabolic constituents such
as choline and lactate during this treatment to see if these can be predictive of long-term
efficacy of therapy.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

determine the best schedule

Outcome Description:

of early and midterm imaging times using DWI-MRI which will distinguish between near complete (90-99%)/complete responders and partial/non-responders

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Marc J. Gollub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Rectal Cancer
  • MRI
  • rectum
  • 13-019
  • Rectal Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021