Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma

N/ANot Yet RecruitingNCT07719634

Assiut University45 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Fibroadenoma

Interventions

microwave ablationDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 .

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 18 months

Secondary Outcomes

Cosmetic outcome - breast shape and symmetry

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

Time frame: 18 months

Cosmetic outcome - scar appearance

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

Time frame: 18 months

Cosmetic outcome - skin pigmentation changes

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

Time frame: 18 months

Patient satisfaction

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

Time frame: 18 months

Data from ClinicalTrials.gov

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