Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: microwave ablation.
- Who it may be relevant to
- Registry conditions: Breast Fibroadenoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
assess the efficacy of MWA in reducing fibroadenoma volume and achieving complete lesion regression at 12 months post-treatment
Detailed description
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
Interventions
- Device microwave ablation
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 fibroad
Primary outcome measures
- assess the efficacy of MWA in reducing fibroadenoma volume [Time frame: 12 months]
- To evaluate the safety profile of MWA (adverse events, complications). [Time frame: 18 months]
Secondary outcome measures (4)
- Cosmetic outcome - breast shape and symmetry [Time frame: 18 months]
- Cosmetic outcome - scar appearance [Time frame: 18 months]
- Cosmetic outcome - skin pigmentation changes [Time frame: 18 months]
- Patient satisfaction [Time frame: 18 months]
Eligibility criteria
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07719634 · breast fibroadenoma MWA