Status:
ACTIVE_NOT_RECRUITING
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
Lead Sponsor:
CivaTech Oncology
Conditions:
Sarcoma
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiat...
Detailed Description
CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can...
Eligibility Criteria
Inclusion
- Subject Signed Inform Consent
- Subject plans to remain in the long-term care of his/her enrolling center/investigators.
- Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
- Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
- Subject is able to undergo surgery
Exclusion
- Is unable or unwilling to comply with protocol requirements.
- Is enrolled in another study/registry not approved by CivaTech Oncology.
- Pregnancy, breast feeding
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04033081
Start Date
April 30 2020
End Date
April 1 2030
Last Update
April 4 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111