Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

CivaTech Oncology

Status and phase: Enrolling; Phase 4

Conditions: Sarcoma

Treatments: Device: CivaSheet

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04033081

CT007

Details and patient eligibility

About

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.

Full 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 be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.

Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CivaSheet Treatment

Experimental group

Description:

Implanted with CivaSheet during tumor removal

Treatment:

Device: CivaSheet