NCT06222788

Brief Summary

The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are:

  • To determine the safe and tolerable dose of NTP in patients with breast cancer;
  • To assess the safety and tolerability of NTP;
  • To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

December 13, 2023

Last Update Submit

June 26, 2024

Conditions

Breast Cancer

Keywords

non-thermal plasma

Outcome Measures

Primary Outcomes (1)

  • Incremental increase of NTP dose to reach maximum safe dose.

    The safety and tolerability of treatment will be evaluated by means of dose-limiting toxicities, adverse events and serious adverse events reports, physical examinations, and laboratory safety evaluations. Dose-limiting toxicities are defined as a grade 4 fever, breast infection, skin ulceration or chest wall necrosis (according to CTCAE v5.0).

    3 months

Secondary Outcomes (2)

  • Number of patients with adverse events linked to the NTP treatment and type of events.

    3 months

  • Number of patients with cosmetic alterations linked to the NTP treatment and type of alterations.

    3 months

Other Outcomes (1)

  • Evidence of cancer cell death and effects on normal tissue in samples treated with NTP ex vivo or in situ.

    15 months

Study Arms (1)

NTP treatment

EXPERIMENTAL

The patients will be treated with NTP intra-operatively.

Device: Convertible Plasma Jet

Interventions

Convertible Plasma JetDEVICE

NTP will be applied to the patients using the Convertible Plasma Jet (CPJ, NexPlasmaGen Inc.)

NTP treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years at the time of signing study consent.
  • ECOG ≤2.
  • Patient with T1-4 breast cancer for groups A and B; patient with T1/T2 breast cancer for group C (based on physical exam, not radiological measurements).
  • Patient is scheduled to undergo a lumpectomy.

You may not qualify if:

  • Prior treatment for the tumor of interest (including chemotherapy, immunotherapy, radiotherapy).
  • Patient planning to or undergoing intraoperative radiotherapy.
  • Diabetes (types I and II).
  • Hypercortisolism.
  • Collagen vascular disease.
  • Patient requiring systemic corticosteroids at physiologic doses exceeding 10 mg/day of prednisone or its equivalent.
  • Patient receiving daily chemotherapy for rheumatological conditions.
  • Pregnancy (a urine pregnancy test must be obtained for non-sterile women of childbearing potential prior to surgery).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal - CHUM

Montreal, Quebec, h2X0A9, Canada

Location

Related Publications (1)

  • Glory A, Patocskai E, Wong P. Breast cancer PAINT: a first-in-human, dose-escalation study to determine the safety of Plasma Adjuvant INtra-operative Treatment in breast cancer patients. BMC Cancer. 2025 Apr 22;25(1):748. doi: 10.1186/s12885-025-14153-5.

    PMID: 40264065DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 25, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)