Clinical trial · Interventional
Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Convertible Plasma Jet | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NTP treatment
- description
- The patients will be treated with NTP intra-operatively.
- interventionNames
- Device: Convertible Plasma Jet
Primary outcomes (1)
- measure
- Incremental increase of NTP dose to reach maximum safe dose.
- timeFrame
- 3 months
- description
- 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).
Secondary outcomes (2)
- measure
- Number of patients with adverse events linked to the NTP treatment and type of events.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDGlory 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 40264065