Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma

NCT07719634 | Not Yet Recruiting

• 1 other identifier: breast fibroadenoma MWA
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

assess the efficacy of MWA in reducing fibroadenoma volume and achieving complete lesion regression at 12 months post-treatment

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (2)

• assess the efficacy of MWA in reducing fibroadenoma volume

  Volume Reduction Ratio (VRR): Calculated to see how much the fibroadenoma has shrunk. Measure 3 orthogonal diameter, calculate volume: L x W x H x0.5 and compare to previous exam.

  12 months

• To evaluate the safety profile of MWA (adverse events, complications).

  the investigators will follow up the patients for any appearance of unwanted changes or any complications

  18 months

Secondary Outcomes (4)

• Cosmetic outcome - breast shape and symmetry

  18 months

• Cosmetic outcome - scar appearance

  18 months

• Cosmetic outcome - skin pigmentation changes

  18 months

• Patient satisfaction

  18 months

Study Arms (1)

breast fibroadenoma

OTHER

Fibroadenoma is a common benign breast lesion resulting from the excess proliferation of connective tissue. Fibroadenomas characteristically contain both stromal and epithelial cells. Fibroadenomas typically occur in women between the ages of 10 and 40 years. It is the most common solid breast mass in women of all ages and the most common breast mass in the adolescent and young adult population.. The lesions are well-defined and well-circumscribed clinically, with normal overlying skin. The lesions are not fixed to the surrounding parenchyma and slide around with palpation, hence the colloquial term a breast "mouse".

Device: microwave ablation

Interventions

microwave ablation DEVICE

Patients will be positioned supine or lateri-cumbent, which fully exposed the breast and permitted surgical disinfection. During the administration of a local anesthetic, the investigators will carefully administer a mixture of 2% lidocaine and 0.9% saline solution into the surrounding breast fibroadenoma to achieve a liquid isolated region to protect the skin, pectoralis, and areola from thermal injury. Under real-time ultrasound guidance, an MWA antenna will be inserted into the breast fibroadenoma, and therapy will be ceased until the hyper echoic area completely cover the entire breast fibroadenoma

breast fibroadenoma

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants ≥ 18 years
• Diagnosed with fibroadenoma by clinical and ultrasonographic signs, core needle biopsy done only if atypical fibroadenoma.
• Lesion(s) measurable by ultrasound (e.g., diameter 0.7 - 3.0 cm),distance from breast lesion to the skin and pectoralis muscle exceeding 10 mm and the lesion away from nipple areola area .
• Symptomatic lesion or patient preference for minimally invasive treatment

You may not qualify if:

• Malignancy or high suspicion of malignancy, BIRADs 4 or more/if pathological proved.
• Active infection.
• Coagulopathy or contraindications to ablation.
• Distance from breast lesion to the skin and pectoralis muscle less than 10 mm and the lesion near nipple areola area .

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share