Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

Neoplasm of Breast Clinical Trial

Official title:

Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02860104
• Other study ID #: 939530lp
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 2, 2016
• Last updated: November 22, 2016
• Start date: December 2012
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 8610-66939530
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm of Breast

Intervention

Device:
• microwave ablation
ultrasound guided percutaneous microwave ablation for breast lesions

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in volume	the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.	5 year	Yes