Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Prior treatment for the tumor of interest (including chemotherapy, immunotherapy, radiotherapy).

Patient planning to or undergoing intraoperative radiotherapy.

Diabetes (types I and II).

Hypercortisolism.

Trial design

Treatments tested in this trial

  • Convertible Plasma Jet

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Ozmosis Research Inc.

Collaborator

Quebec Breast Cancer Foundation

Collaborator