Registry of Sarcoma Patients Treated with Permanent Low Dose Radiation CivaSheet® Implants

Sponsor: CivaTech Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04033081

Provider View

This study is exploring the safety and effects of using a permanent radiation implant called CivaSheet® to treat sarcoma, a type of cancer, in areas like the abdomen and pelvis. The CivaSheet® is designed to deliver targeted low dose radiation to help prevent cancer from coming back after surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and potential side effects of using a permanent radiation implant called CivaSheet® in patients with sarcoma, a type of cancer that can occur in the abdomen, pelvis, and other areas. The CivaSheet® is a flexible device that delivers low dose radiation directly to the area where the tumor was removed, aiming to reduce the chance of the cancer returning.

Description

CivaSheet® is a medical device approved by the FDA, developed by CivaTech Oncology®. It consists of small radioactive sources made of palladium-103, which are placed on a flexible, bio-compatible membrane. This sheet can be cut to fit the surgical area and is designed to deliver precise radiation to the site where the tumor was removed, potentially preventing the cancer from coming back.

Sarcoma is a type of cancer that often returns after treatment, with recurrence rates as high as 80% depending on the type and location of the cancer. In this study, the CivaSheet® will be implanted at the site where the tumor was removed during surgery. The main goal is to monitor any immediate side effects from the treatment. The study will also track how the cancer progresses and if it returns.

Eligibility Criteria

Inclusion Criteria

  • Must have signed an informed consent form.
  • Plans to continue receiving care at the center where they are enrolled.
  • Sarcoma must be visible on imaging tests, either confirmed by a biopsy or suspected based on imaging if a biopsy is not possible.
  • Sarcoma must be located in the retroperitoneum, abdomen, pelvis, or trunk.
  • Must be able to undergo surgery.

Exclusion Criteria

  • Unable or unwilling to follow the study requirements.
  • Participating in another study not approved by CivaTech Oncology.
  • Pregnant or breastfeeding.

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