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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
determine the best schedule
of early and midterm imaging times using DWI-MRI which will distinguish between near complete (90-99%)/complete responders and partial/non-responders
3 years
No
Marc J. Gollub, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
13-019
NCT01830582
April 2013
April 2015
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |