A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT03151642
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The purpose of this research study will be to determine the sensitivity and specificity of dwMRI metrics to assess tumor response following neoadjuvant chemoradiation in esophageal cancer. This pilot study will generate the preliminary data needed for the design of a statistically-justified trial that would investigate dwMRI as an integral biomarker to stratify patients for escalated therapy to improve outcomes. We hope to develop dwMRI as a predictive clinical tool for a personalized treatment model that can identify patients who may be candidates for organ-preservation or treatment intensification to improve outcomes in esophageal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-05
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Primary Completion: 2019-08-23
• Status Verified: 2021-04
• Study Completion: 2021-04-23
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
• Patients with AJCC 7th edition clinical stage IIB-IIIC
• Patients will be treated with neoadjuvant chemoradiotherapy for this condition
• Patients must be > 18 years of age
• Patients must be able to provide informed consent
• Patients must be surgical candidates
• Patients must be able to tolerate MR imaging required by protocol

Exclusion Criteria

• Patients with primary tumors located above the carina
• Prior abdominal radiation therapy with fields overlapping the current fields
• Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice
• Presence of MRI-incompatible metallic objects or implanted medical devices in the body (including but not limited to: non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, metal fragments in the eye or central nervous system)
• Weight greater than that allowable by the MRI table

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of MRIs	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States