An interventional study of Convertible Plasma Jet in Breast Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Other
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:
Non-thermal plasma (NTP) refers to an ionized gas composed of ions, electrons and other reactive agents. The anti-cancerous properties of NTP have been proven in vitro and in vivo. The 10-year local recurrence risk (LRR) in breast cancer patients after a breast conservation therapy (i.e., lumpectomy, typically followed by radiation therapy) is still as high as 15-20%. NTP could be used to further treat the tumor bed to reduce the LRR.
The primary objective of this clinical trial is to determine the safe and tolerable dose of NTP treatment following breast cancer lumpectomy. The secondary objectives are to assess the safety and tolerability of NTP and to assess the cosmetic effects of NTP treatment in patients with breast cancer. Our exploratory objective is to assess the impact of NTP treatment on cancerous and normal tissues. Patients are followed for 3 months after NTP treatment. The patients are divided into 3 groups: group A (n=3): NTP treatment of part of the tumor bed ex vivo. Group B (n=3): NTP treatment of part of the tumor bed in situ (all treated tissues are removed for analysis). Group C (n=6-24): dose escalation per "3+3 Design" up to a maximum dose level 3. NTP treatment of part of the tumor bed in situ (the treated parts of the tumor bed will not be excised, except a small portion for analysis).
The safety and tolerability of treatment will be evaluated by means of dose limiting toxicities, adverse events (AEs) and serious adverse events reports, physical examinations, and laboratory safety evaluations. AEs will be coded according to the CTCAE v5.0. The results will be tabulated to examine their frequency, grade, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly. The number of patients with cosmetic alterations linked to the NTP treatment and type of alterations will be assessed through the quality of life questionnaires (questions on breast appearance and texture) and through the photo collection. This is the first clinical trail to study the safety and tolerability of NTP in an all breast-cancer patient group.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients will be treated with NTP intra-operatively.
Device: Convertible Plasma Jet
NTP will be applied to the patients using the Convertible Plasma Jet (CPJ, NexPlasmaGen Inc.)
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).
Time frame: 3 months
Number of patients with adverse events linked to the NTP treatment and type of events.
Adverse events will be coded according to the CTCAE Version 5.0. The results will be tabulated to examine their frequency, organ systems affected, grade, and relationship to study treatment.
Time frame: 3 months
Number of patients with cosmetic alterations linked to the NTP treatment and type of alterations.
This will be assessed through the quality of life questionnaires (questions on breast appearance and texture) and through the photo collection (pictures of the treated breast before/after NTP treatment).
Time frame: 3 months
Evidence of cancer cell death and effects on normal tissue in samples treated with NTP ex vivo or in situ.
Ex vivo or in situ treatment of cancerous and normal tissues with NTP followed by fixation of the tissues and analysis by immunofluorescence.
Time frame: 15 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre hospitalier de l'Université de Montréal (CHUM)