Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

NCT04033081 · tracked via the Priya Life Science USA tracker

Sponsor

CivaTech Oncology

Phase

Phase 4

Started

2020-04-30

Last updated

2026-03-23

Condition(s) studied

Sarcoma

Investigational drug(s) / intervention(s)

CivaSheet

CivaSheet: Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence

Study 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) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Subject Signed Inform Consent 2. Subject plans to remain in the long-term care of his/her enrolling center/investigators. 3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate. 4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk 5. Subject is able to undergo surgery Exclusion Criteria: 1. Is unable or unwilling to comply with protocol requirements. 2. Is enrolled in another study/registry not approved by CivaTech Oncology. 3. Pregnancy, breast feeding

Primary outcome measure(s)

Rate of acute toxicity — 90 days post implant
rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria

Trial sites (1)

Facility	City	Region	Status
Fox Chase Cancer Center	Philadelphia	Pennsylvania

More CivaTech Oncology trials in the USA

Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet® Recruiting

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04033081 on ClinicalTrials.gov ↗ ← All trials in the USA