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

NCT06796634 | Recruiting DMC

• 2 other identifiers: ONZ-2024-0090B6702024000142
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• - Histology:

  Following resection, FFPE sections will be assessed morphologically, particularly for the extent of tumor necrosis using haematoxylin and eosin staining. IHC staining will be performed to investigate mechanisms of autophagia (p62 and LC3B), apoptosis (cleaved caspase 3) and proliferation (ki67). * Extent of tumor necrosis: morphological assessment * Proliferation: Ki67 via MIB1 * Autophagia: p62 or LC3B * Apoptosis: Caspase 3 antibodies

  1 year

Study Arms (1)

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

EXPERIMENTAL

* 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.

Device: J-plasma

Interventions

J-plasma DEVICE

* 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Central Study Contacts

Wim Ceelen, professor

CONTACT

+3293326251; wim.ceelen@ugent.be

Sarah Cosyns, doctor

CONTACT

+3293321562; sarah.cosyns@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: August 21, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

BE (1)