Early-stage breast cancer requiring cryoablation prior to surgical treatment Breast cancer
Conditions
Interventions
Early-stage Breast Cancer
Device Feasibility
Breast cancer
Sponsors
Bumrungrad Hospital Public Company Limited
ICECURE Medical Ltd.
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients receiving treatment at Thammasat University Hospital or Bumrungrad Hospital International 2. Age greater than or equal to 20 years. 3. Read and understand Thai language. 4. Consent to participate in the research by knowing and understanding the information of the research project as stated in the research outline. and voluntarily signed a letter of consent to participate in the research 5. Have results of mammography and breast ultrasound. 6. Female breast cancer patients diagnosed using a core needle biopsy. 7. There is a record of laboratory testing with Estrogen receptor (ER), Progesterone receptor (PR), HER-2/neu and Ki-67 (Estrogen receptor (ER), Progesterone receptor (PR), HER-2 test. /neu and Ki-67 are standard treatment tests. To consider additional treatment after surgery which not related to the interpretation of research results 8. The breast cancer lump has a diameter of the longest lump less than or equal to 15 millimeters and is a single lump (Unifocal) total 1 lump, which has been confirmed using Magnetic Resonance Imaging (MRI). 9. No signs of breast cancer spreading to the axillary lymph nodes from physical examination or imaging of the lymph nodes in the axilla. 10. Agree to use birth control methods recommended by the research doctor throughout the period of participation in the research project
Exclusion criteria
Exclusion criteria: 1. Pregnant patient 2. The tumor cannot be clearly seen on a breast ultrasound. 3. The cancer has spread to the skin or chest wall. which is detected through a physical examination or through diagnostic radiographs 4. Unable to receive treatment or continuous follow-up for at least 1 month. 5. Creatinine levels in the blood are higher than the normal lab range of each institution. 6. Have a history of allergy to contrast media and/or seafood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 1 year Tumor result | — |
Secondary
| Measure | Time frame |
|---|---|
| safety after 10 day Post Cryoablation Adverse Effect | — |
Countries
Thailand
Contacts
Public ContactSasithorn Sujarittanakarn
Department of Surgery, Faculty of Medicine
Outcome results
None listed