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Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma (mua)

17. juli 2026 opdateret af: Asmaa Mohammed Abdel Hamed Ali, Assiut University
assess the efficacy of MWA in reducing fibroadenoma volume and achieving complete lesion regression at 12 months post-treatment

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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 .

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: breast fibroadenoma
Fibroadenoma is a common benign breast lesion resulting from the excess proliferation of connective tissue. Fibroadenomas characteristically contain both stromal and epithelial cells. Fibroadenomas typically occur in women between the ages of 10 and 40 years. It is the most common solid breast mass in women of all ages and the most common breast mass in the adolescent and young adult population.. The lesions are well-defined and well-circumscribed clinically, with normal overlying skin. The lesions are not fixed to the surrounding parenchyma and slide around with palpation, hence the colloquial term a breast "mouse".
Enhed: 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 fibroadenoma, and therapy will be ceased until the hyper echoic area completely cover the entire breast fibroadenoma

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
assess the efficacy of MWA in reducing fibroadenoma volume
Tidsramme: 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.
12 months
To evaluate the safety profile of MWA (adverse events, complications).
Tidsramme: 18 months
the investigators will follow up the patients for any appearance of unwanted changes or any complications
18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cosmetic outcome - breast shape and symmetry
Tidsramme: 18 months
Assessment of breast shape and symmetry using the Breast Symmetry Scale (1-4), where 1 = excellent symmetry and 4 = marked deformity.
18 months
Cosmetic outcome - scar appearance
Tidsramme: 18 months
Assessment of skin scar quality using the Patient and Observer Scar Assessment Scale (POSAS) or Vancouver Scar Scale.
18 months
Cosmetic outcome - skin pigmentation changes
Tidsramme: 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.
18 months
Patient satisfaction
Tidsramme: 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
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • breast fibroadenoma MWA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Bryst fibroadenom

Kliniske forsøg med microwave ablation

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