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NCT Number: NCT06796634

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

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.

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Key information

Conditions

Cold Atmospheric Plasma (CAP) J-Plasma Peritoneal Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. - Histology:

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Cosyns, doctor

CONTACT

[email protected]

+3293321562

Wim Ceelen, professor

CONTACT

[email protected]

+3293326251

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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