Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes (MWA-FA)

September 11, 2026 updated by: Mohammad Omar Mohammad Selmy, Al-Azhar University

Ultrasound-Guided Microwave Ablation for Treatment of Breast Fibroadenoma: Prospective Evaluation of Safety and Cosmetic Outcome

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast fibroadenoma is a common benign breast tumor, particularly in young women. Many fibroadenomas do not require treatment and can be managed with clinical and ultrasound follow-up. However, treatment may be considered when a fibroadenoma is symptomatic, enlarging, causes cosmetic concerns, or causes significant patient anxiety.

Surgical excision is an effective treatment for symptomatic fibroadenoma, but it may be associated with pain, scarring, changes in breast shape, and other procedure-related complications. These concerns have led to the development of minimally invasive treatment options that aim to treat the fibroadenoma while preserving the surrounding breast tissue.

Microwave ablation is a minimally invasive technique that uses microwave energy to generate heat within the targeted tissue, resulting in tissue destruction. When performed under ultrasound guidance, the treatment can be directed to the fibroadenoma while allowing real-time visualization of the treated area and surrounding breast structures.

This study is designed to evaluate ultrasound-guided microwave ablation as a minimally invasive treatment option for selected adult women with breast fibroadenoma. The study will assess the safety of the procedure and the clinical and cosmetic outcomes following treatment. It will also evaluate changes in pain, patient satisfaction, and the appearance of the treated fibroadenoma during follow-up.

The study may provide additional clinical information about the use of ultrasound-guided microwave ablation as a breast-preserving treatment option for selected patients with breast fibroadenoma.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt, 71524
        • Al-Azhar University Hospitals - Assiut
        • Contact:
        • Contact:
        • Principal Investigator:
          • mohammad omar selmy, M.B.B.Ch.
        • Principal Investigator:
          • Tarek Mohammad Mansour, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

inclusion Criteria:

Female patients aged 18 years or older. 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microwave Ablation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-Related Complications
Time Frame: Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
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
Time Frame: 3, 6, and 12 months after treatment
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
Time Frame: 3, 6, and 12 months after treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity Assessed by the Visual Analog Scale (VAS)
Time Frame: Baseline (before the procedure), 3, 6, and 12 months after treatment
Pain severity will be assessed using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0, indicating no pain, to 10, indicating the worst pain imaginable. Patients will be asked to indicate the intensity of pain experienced before the procedure and during follow-up after ultrasound-guided microwave ablation. Changes in VAS scores over the follow-up period will be assessed to evaluate improvement in pain and local symptoms.
Baseline (before the procedure), 3, 6, and 12 months after treatment
Residual Lesion or Lesion Regrowth
Time Frame: 3, 6, and 12 months after treatment
Ultrasound will be used to evaluate post-ablation changes, assess the treated fibroadenoma, detect any residual viable tissue, and identify lesion regrowth during follow-up.
3, 6, and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: tarek mohammad mansour, MD, Al-Azhar University, Faculty of Medicine, Assiut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diag.I.Rad-900/2026/09/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers. Collected data will be used only for the purposes of this study, with participant confidentiality and privacy maintained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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