Search / Trial NCT06222788

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

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jan 15, 2024

Trial Information

Current as of October 03, 2024

Not yet recruiting

Keywords

Non Thermal Plasma

Description

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 o...

Gender

FEMALE

Eligibility criteria

  • 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).

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Montréal, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0