Skip to content

Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer

Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer - Safety and effectiveness of non resection ultrasound guided cryotherapy for localized early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031222
Enrollment
10
Registered
2018-02-25
Start date
2018-04-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

IceSense3(IceCureCo.,Israel)

Sponsors

St.Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1:ECOG Performance Status(PS)0~1 2:Women20to85years old 3:For the first time, it is diagnosed as invasive breast cancer by histologic examination 4:Subtype diagnosis results Hormone receptor positive, HER2 protein expression negative(no DNA amplification), Ki-67<=20% 5:Breast cancer lesions with primary lesions of MMG, US, CT, MRI and lesion spreads of1.5cm or less are the primary lesions. 6:It is diagnosed that there is a high possibility that the sentinel lymph node(SLN)is negative in the preoperative image diagnosis. 7:Sentinel lymph node biopsy and radiation therapy after cryotherapy are possible. 8:There is no systemic infectious disease with poor control9:After sufficient explanation, patient informed consent(IC) was obtained in writing.

Exclusion criteria

Exclusion criteria: 1:If there is an offer to study non-participation from patients, stop this and exclude it from the study. 2:Patient with distant metastasis. 3:Even if we meet the indication criteria 1,2,3 it is diagnosed as invasive lobular carcinoma, invasive micro papillary carcinoma. 4:MMG, US, CT, MRI admitted lymph duct lesions and daughter nodules around. 5:Cases in proximity of frostbite dangerous skin and chest muscle are not indicated. 6:Other things that the doctor in charge considers inappropriate.

Design outcomes

Primary

MeasureTime frame
Vacuum-assisted biopsy is performed to check whether viable cancer tissue remains 1 month after non-resected ultrasound guided cryotherapy.

Countries

Japan

Contacts

Public ContactHisanori Kawamoto

St.Marianna University School of Medicine Breast Endocrine Surgery

h-kawamoto@marianna-u.ac.jp81-44-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026