Pathological outcome of cryoablation prior to surgical treatment in early-stage breast cancer: a pilot study

Recruiting

• Conditions: Early-stage breast cancer requiring cryoablation prior to surgical treatment; Breast cancer

• Registration Number: TCTR20240519002
• Lead Sponsor: Bumrungrad Hospital Public Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-19
• Last Update Posted: 19 August 2024
• Study Completion: 2027-06-08

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy 1 year Tumor result

Secondary Outcome Measures

Name	Time	Method
safety after 10 day Post Cryoablation Adverse Effect