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Clinical Trials in the USA / NCT04033081
Active, not recruiting Phase 4

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
No
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)

FacilityCityRegionStatus
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

Other trials for the same condition

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas Recruiting
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors Recruiting
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors Active, not recruiting
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors Active, not recruiting
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Recruiting
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