Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

Phase 2

• Conditions: Neoplasm of Breast
• Interventions: Device: microwave ablation

• Registration Number: NCT02860104
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.

Detailed Description

A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be measured and analyzed.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• breast lesion proved by using core-needle biopsy;
• for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;
• distance of at least 1.0cm to papilla with the patients supine;
• the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;
• the patient with evidently psychological pressure due to the occurrence of the lesion;
• patients unwilling or refused to receive other treatment and presence of an appropriate route for percutaneous puncture under US guidance.

Exclusion Criteria

• patients who were pregnant or breast-feeding;
• patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;
• patients during menstrual period;
• patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microwave ablation	microwave ablation	microwave ablation

Primary Outcome Measures

Name	Time	Method
reduction in volume	5 year	the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = \[(initial volume - final volume) × 100\]/initial volume.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China