Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes

NCT07823907 | Not Yet Recruiting

• 1 other identifier: Diag.I.Rad-900/2026/09/008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if ultrasound-guided microwave ablation is a safe and effective treatment for breast fibroadenoma in adult women. It will also learn about the cosmetic outcome and patient satisfaction after treatment. The main questions it aims to answer are: What medical problems or complications do participants have after microwave ablation? Does the treated breast fibroadenoma decrease in size during follow-up? Does pain improve after treatment? What are the cosmetic outcomes and how satisfied are participants with the treatment? Researchers will evaluate the treated fibroadenoma using clinical examinations and breast ultrasound during 12 months of follow-up. Participants will: Have a clinical examination, breast ultrasound, and core needle biopsy before treatment Receive ultrasound-guided microwave ablation under local anesthesia Have follow-up visits at 3, 6, and 12 months after treatment Have breast ultrasound examinations during follow-up Have their pain, treatment-related complications, cosmetic outcome, and satisfaction assessed during follow-up

Conditions

Breast Fibroadenoma

Keywords

Breast Fibroadenoma; Microwave Ablation

Outcome Measures

Primary Outcomes (3)

• Procedure-Related Complications

  The occurrence and type of procedure-related complications following ultrasound-guided microwave ablation of breast fibroadenoma will be assessed, including immediate and delayed complications such as pain, bleeding, hematoma, skin injury, infection, and other procedure-related adverse events.

  Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.

• Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale

  Cosmetic outcome of the treated breast will be assessed using the Harvard Breast Cosmesis Scale during follow-up. The assessment will evaluate the overall cosmetic appearance of the treated breast, including breast shape, contour, symmetry, and the presence of visible treatment-related changes or deformity. The cosmetic outcome will be assessed at each scheduled follow-up visit after ultrasound-guided microwave ablation.

  3, 6, and 12 months after treatment

• Patient Satisfaction After Microwave Ablation

  Patient satisfaction with the treatment outcome will be assessed using a structured patient satisfaction questionnaire during follow-up. The assessment will address the patient's overall satisfaction with the treatment, perceived cosmetic outcome, improvement in symptoms, and acceptance of the procedure as a minimally invasive treatment option.

  3, 6, and 12 months after treatment

Secondary Outcomes (2)

• Pain Severity Assessed by the Visual Analog Scale (VAS)

  Baseline (before the procedure), 3, 6, and 12 months after treatment

• Residual Lesion or Lesion Regrowth

  3, 6, and 12 months after treatment

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

Participants in this arm will receive ultrasound-guided microwave ablation for the treatment of breast fibroadenoma. Microwave ablation will be performed under local anesthesia using real-time ultrasound guidance to target the fibroadenoma.

Device: Ultrasound-Guided Microwave Ablation

Interventions

Ultrasound-Guided Microwave Ablation DEVICE

Ultrasound-guided microwave ablation will be performed using a microwave ablation system under real-time ultrasound guidance. The microwave antenna will be positioned within the breast fibroadenoma under ultrasound guidance, and microwave energy will be delivered to the targeted lesion to achieve thermal ablation. The procedure will be performed under local anesthesia. Ablation parameters will be selected according to the characteristics of the lesion and the manufacturer's recommendations.

Microwave Ablation

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18 years .
• Histologically proven breast fibroadenoma by tru-cut biopsy.
• Symptomatic fibroadenoma or fibroadenoma causing cosmetic concern.
• Lesion size suitable for microwave ablation (approximately 1-4 cm).
• Patient acceptance of the procedure and written informed consent.

You may not qualify if:

• Suspicious or malignant breast lesion.
• Pregnancy.
• Coagulopathy or bleeding tendency.
• Active breast infection.
• Lesion with direct adherence to or involvement of the skin.
• Lesion unsuitable for safe antenna placement.
• Patient refusal to participate or inability to complete follow-up.
• Lesion with direct adherence to or involvement of the skin.
• Lesion unsuitable for safe antenna placement.
• Patient refusal to participate or inability to complete follow-up.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospitals - Assiut

Asyut, 71524, Egypt

Location

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 Officials

• tarek m mansour, MD

  Al-Azhar University, Faculty of Medicine, Assiut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohammad omar selmy, M.B.B.Ch

CONTACT

+201090190759; apoomar4455@gmail.com

Ahmed Ab Ahmed, MD

CONTACT

+201005781485; drahmedazkool@gmail.com

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: Resident of Diagnostic and Interventional Radiology Department

Model Details: This is a prospective, single-group, single-arm interventional study. All enrolled participants will receive ultrasound-guided microwave ablation for the treatment of breast fibroadenoma. There will be no control or comparator group. Participants will be evaluated prospectively for safety, clinical outcomes, cosmetic outcome, pain, patient satisfaction, and ultrasound findings during follow-up.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)