NCT02902107

Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.

Conditions

• Abdominal Malignancy
• Pelvic Malignancy

Interventions

Type	Name	Description
DEVICE	CivaSheet
RADIATION	Brachytherapy
PROCEDURE	surgical resection

Timeline

• Start date: 2016-09-09
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2016-09-15
• Last updated: 2024-10-21

Locations

1 site across 1 country: United States