Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Cold Atmospheric Plasma (CAP); J-Plasma; Peritoneal Tumor

Treatments: Device: J-plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT06796634

ONZ-2024-0090

B6702024000142 (Other Identifier)

Details and patient eligibility

About

There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma
• Written informed consent
• Age ≥ 18 years.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi

Experimental group

Description:

* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP. * Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations: * 15 W, 30W, or 45W * 2, 5, or 10 seconds. * The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry.

Treatment:

Device: J-plasma