Breast Fibroadenoma
Conditions
Keywords
Breast Fibroadenoma, Microwave Ablation
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
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.
Interventions
DEVICEUltrasound-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.
Sponsors
Al-Azhar University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-Related Complications | 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. |
| Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale | 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. |
| Patient Satisfaction After Microwave Ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity Assessed by the Visual Analog Scale (VAS) | 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. |
| Residual Lesion or Lesion Regrowth | 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. |
Countries
Egypt
Contacts
CONTACTmohammad omar selmy, M.B.B.Ch
CONTACTAhmed Abd-Elrady Ahmed, MD
PRINCIPAL_INVESTIGATORtarek mohammad mansour, MD
Al-Azhar University, Faculty of Medicine, Assiut
Outcome results
None listed