Recruiting

NTP

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06222788

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Convertible Plasma Jet

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06222788

Start date

Apr 7, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years at the time of signing study consent.
2. ECOG ≤2.
3. 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).
4. Patient is scheduled to undergo a lumpectomy.

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: NTP treatment

The patients will be treated with NTP intra-operatively.

Interventions

Convertible Plasma Jet

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

Primary outcome measure

  • Incremental increase of NTP dose to reach maximum safe dose. [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal - CHUM

Recruiting

Montreal, Quebec, Canada, h2X0A9

Contacts

Principal Investigator:

Philip Wong, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • non-thermal plasma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-14.