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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03151642

Collaborator

(none)

Enrollment

Location

48.6

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Radiation: Chemotherapy Radiation: Radiation Therapy Procedure: Surgery Device: MRI Imaging Other: Blood Draws

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 5, 2017

Actual Primary Completion Date :

Aug 23, 2019

Actual Study Completion Date :

Apr 23, 2021

Outcome Measures

Primary Outcome Measures

Number of MRIs [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Edgar Ben-Josef, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT03151642

Other Study ID Numbers:

UPCC 10217

First Posted:

May 12, 2017

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophageal Neoplasms

Study Results

No Results Posted as of Apr 26, 2021