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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830582
• Other study ID #: 13-019
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: June 21, 2017
• Start date: April 9, 2013
• Est. completion date: June 20, 2017

Study information

• Verified date: June 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Advanced MR Imaging

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the best MR imaging schedule	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	3 years
Secondary	Determine if the best imaging schedule for DCE is the same as for DWI	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

External Links

•   Memorial Sloan Kettering Cancer Center