A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION
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|ClinicalTrials.gov Identifier: NCT03151642|
Recruitment Status : Suspended (Covid-19)
First Posted : May 12, 2017
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Radiation: Chemotherapy Radiation: Radiation Therapy Procedure: Surgery Device: MRI Imaging Other: Blood Draws|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A PILOT STUDY OF DIFFUSION WEIGHTED MRI TO ASSESS ESOPHAGEAL TUMOR RESONSE TO NEOADJUVANT CHEMORADIATION|
|Actual Study Start Date :||April 5, 2017|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||April 2025|
- Radiation: Chemotherapy
Patients will have their chemotherapy coordinated through the Medical Oncology department at the University of Pennsylvania, and will be followed by Medical Oncology at Penn during chemoradiation. As part of the standard of care for locally advanced esophageal cancer, neoadjuvant concurrent chemotherapy will likely consist of weekly carboplatin and paclitaxel, beginning within 1 day of starting radiation therapy and continuing until the completion of radiation treatment. Alternative chemotherapy regimens, dose adjustments or delays in administration will be determined at the discretion of the treating medical oncologist and recorded in the patient's chart.
- Radiation: Radiation Therapy
Patients will have their radiation therapy coordinated and performed through the Radiation Oncology Department at the University of Pennsylvania. The development and delivery of the patient's radiation treatment plan will be at the discretion of the treating radiation oncologist, and details will be recorded in the patient's chart.
- Procedure: Surgery
Patients will have their surgery coordinated and performed through Thoracic Surgery department at the University of Pennsylvania. Patients will undergo esophagectomy 4-8 weeks after the completion of neoadjuvant chemoradiation as part of the standard of care.
- Device: MRI Imaging
A total of 40 paired MRI examinations from eligible participants will be collected in the Department of Radiology at the Hospital of the University of Pennsylvania. Participants will undergo two 1.5T MRI studies performed at two time points: (1) within 28 days prior to starting neoadjuvant chemoradiation, and (2) between radiation fraction 8-13 during treatment. The quantitative imaging studies for the trial (DWI) will be performed with and without respiratory gating using a navigator, with B values of 0, 100, 600 and 800 s/mm2.
- Other: Blood Draws
The procedure of blood collection for each patient will be as follows: the total amount being drawn each time will be approximately 30 cc. Approximately 25 ml of blood will be collected into heparinized tubes, and immediately placed on ice in a prepared plastic bag and transported to the laboratory for processing within 1 hour. If necessary, we may need up to 2 hours in order to begin processing the blood; in the event that longer than this time period has transpired, the sample will be deemed inadequate for processing purposes. The first blood draw will be obtained prior to the first fraction of radiation treatment and will be coordinated to occur at the time of pre-treatment MRI. Thereafter, the second sample will be obtained during chemoradiation therapy, between fraction 8-13 and the blood draw will be coordinated with the on-treatment MRI scan.
- Number of MRIs [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151642
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Edgar Ben-Josef, MD||Abramson Cancer Center of the University of Pennsylvania|