A Pilot Study of the CivaSheet to Deliver Intraoperative Radiation Therapy for Abdominal and Pelvic Tumors

Full Title

A Phase I Feasibility Trial of Unidirectional Low Dose Rate Brachytherapy for Patients with Abdominal and Pelvic Malignancy Undergoing Surgical Resection Requiring Intraoperative Radiation Therapy

Purpose

Radiation therapy delivered directly to tissue during surgery is called intraoperative radiation therapy (IORT). It is usually done by implanting radioactive seeds to the tumor site. This procedure is typically performed using a semi-flexible silicone device that delivers the radiation while the patient is still asleep in the operating room. The device is temporary and is removed afterward.

In this study, researchers are evaluating the delivery of IORT using a new device called the CivaSheet. It is very thin and flexible and can be cut to size. Moreover, it is permanently left in place. It is also shielded on one side with gold, allowing the radiation to be released in only one direction and resulting in less radiation to healthy tissue.

In this study, doctors are evaluating the feasibility of using the CivaSheet in patients who will be having surgery to remove an advanced abdominal and pelvic cancer and are candidates for IORT. They will also observe any side effects associated with the device.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced or recurrent solid tumor of the abdomen or pelvis that will be surgically removed.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Abraham Wu at 212-639-5257.

Protocol

16-605

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Locations