Active — Not RecruitingPhase 4

Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

United States100 participantsStarted 2020-04-30

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Is unable or unwilling to comply with protocol requirements.
✕. Is enrolled in another study/registry not approved by CivaTech Oncology.
✕. Pregnancy, breast feeding

What they're measuring

Rate of acute toxicity

Timeframe: 90 days post implant

Trial details

NCT IDNCT04033081

SponsorCivaTech Oncology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

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