Clinical trial NCT02860104: Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions
Official title: Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Neoplasm of Breast
Keywords: microwave ablation
breast
multicenter
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: reduction in volume
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: STUDY_CHAIR
References:
citation: Yang Q, Li H, Chen BH, He GZ, Wu XP, Wang LX, Wu H, Dou JP, Han ZY, Zhang J, Yu XL, Yu J, Liang P. Ultrasound-guided percutaneous microwave ablation for 755 benign breast lesions: a prospective multicenter study. Eur Radiol. 2020 Sep;30(9):5029-5038. doi: 10.1007/s00330-020-06868-9. Epub 2020 Apr 30.
citation: Yu J, Wu H, Meng XW, Mu MJ, Dou JP, Ahmed M, Liang P. Ultrasound-guided percutaneous microwave ablation of central intraductal papilloma: a prospective pilot study. Int J Hyperthermia. 2019;36(1):606-612. doi: 10.1080/02656736.2019.1619849.