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NCT Number: NCT07719634

Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma

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

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Key information

About this study

Breast fibroadenomas are commonly seen among women worldwide, with the incidence having increased over the past few decades. The breast fibroadenoma arise due to proliferation of ductal or lobular tissue, and their treatment is controversial. Small asymptomatic breast lesions generally do not require treatment, and some surgeons tend to favor conservative management of breast fibroadenoma with regular follow-up, which should be accompanied by auxiliary examination (i.e., ultrasound and/or mammography and pathological assessment) every 3-6 months in order to dynamically monitor the status of breast lesions. However, some patients with large-sized breast fibroadenomas suffering from pain or anxiety are not satisfied with the conservative management approach and seek for treatment. Thus, it is necessary to excise part of the breast fibroadenoma according to therapeutic options that depend on different presenting situations Surgical resection is the most effective treatment option for patients suffering from breast lesions, although it is an invasive procedure. The patients much prefer a better cosmetic outcome and fewer surgically associated complications, which are commonly associated with minimally invasive procedures. Ultrasound-guided percutaneous microwave ablation (MWA) is a new minimally invasive treatment technology used in breast fibroadenoma and has emerged as a hot topic of clinical exploration in recent years. MWA has already shown promising results in treating liver carcinoma and pulmonary tumors, and in the settings of adrenal and renal malignancies Currently, in relation to benign lesions, MWA is considered a promising treatment option for patients with benign thyroid nodules given its advantage of being minimally invasive, scar-free, and relatively safe, and is associated with fewer post-operative complications.

To the best of our knowledge, MWA, as a thermal ablation technique, is increasingly being accepted by surgeons and clearly needs to be evaluated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 .

Treatment and study plan

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

Primary outcomes

  1. assess the efficacy of MWA in reducing fibroadenoma volume

    Time frame: 12 months

    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.

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

    Time frame: 18 months

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

Secondary outcomes

  1. Cosmetic outcome - breast shape and symmetry

    Time frame: 18 months

    Assessment of breast shape and symmetry using the Breast Symmetry Scale (1-4), where 1 = excellent symmetry and 4 = marked deformity.

  2. Cosmetic outcome - scar appearance

    Time frame: 18 months

    Assessment of skin scar quality using the Patient and Observer Scar Assessment Scale (POSAS) or Vancouver Scar Scale.

  3. Cosmetic outcome - skin pigmentation changes

    Time frame: 18 months

    Assessment of hyperpigmentation or hypopigmentation at the ablation site compared to the contralateral breast, graded as: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  4. Patient satisfaction

    Time frame: 18 months

    Assessment of patient satisfaction with the overall procedure and cosmetic results using a 5-point Likert scale.

    • Minimum Value: 1 (Very dissatisfied)
    • Maximum Value: 5 (Very satisfied)
    • Higher score indicates: Better outcome

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: mua

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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