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Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma

ConditionBreast Fibroadenoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 .

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: breast fibroadenomaOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: