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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal - CHUM
RECRUITING
Montreal
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 30
Treatments
Experimental: NTP treatment
The patients will be treated with NTP intra-operatively.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Ozmosis Research Inc., Quebec Breast Cancer Foundation

This content was sourced from clinicaltrials.gov