A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/2/2017 |
| Start Date: | April 5, 2017 |
| End Date: | April 2020 |
| Contact: | Edgar Ben-Josef, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
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.
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.
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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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