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Single-arm and exploratory study of high-intensity focused ultrasound in the treatment of breast fibroadenoma

Single-arm and exploratory study of high-intensity focused ultrasound in the treatment of breast fibroadenoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077417
Enrollment
Unknown
Registered
2023-11-08
Start date
2021-01-18
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Breast fibroadenoma

Interventions

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Gender female; age 18-70 years old; single solid lesion in unilateral breast; breast imaging diagnosis BI-RADS2-3; lesions confirmed by puncture pathology as breast fibroadenoma; lesions 2-5cm size, the focus can be detected by ultrasound; the edge of the focus is more than 2cm from the nipple projection; in the prone position, the focus is located by airborne ultrasound, and the superficial edge is = 1cm from the skin surface. Volunteer to participate in the study, willing to cooperate with the completion of relevant data collection.

Exclusion criteria

Exclusion criteria: The patients in the treatment-related area have received radiotherapy; the patient is pregnant or lactating; the skin in the treatment area has severe scars (protruding the skin surface, width = 1cm); the breast skin in the treatment-related area suffers from infection, ulceration or other skin diseases that affect HIFU treatment; has other malignant tumors and is less than 1 year after the end of treatment; severe cardiopulmonary diseases, can not tolerate prone position for more than 30 minutes. There are surgical taboos; existing breast implants. Those who meet any of the above exclusion criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Efficacy (Changes in coagulation necrosis rate and size of lesions);Safety;

Secondary

MeasureTime frame
Quality of life;

Countries

China

Contacts

Public ContactYang Hongwei

Suining Central Hospital

yinheng5511@163.com+86 180 9082 9136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026