Comparison of Microwave Ablation With Cryoablation for Breast Tumor

Breast Tumor Clinical Trial

Official title:

Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286413
• Other study ID #: 66939530yj
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: September 15, 2017
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2017
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Dr.
• Phone: 66937981
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in two centers of China will be recruited in this study and underwent US-guided percutaneous MWA and cryoablation 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 compared and analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis.

Exclusion Criteria:

• (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor
• Cryoablation
• Microwave Ablation

Intervention

Procedure:
• microwave ablation
Microwave ablation and cryoablation are both thermal ablation techniques for minimally invasive treatment of breast tumor. They are performed percutaneously by ultrasound guidance.The tumor can be completely killed without injurying adjacent tissue.

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	volume reduce rate	divide the volume of ablation zone by unablated lesion volume	3 year
Primary	overall survival		5 year
Secondary	local tumor progress	any nodular occurence adjacent to the ablation zone during the follow-up	5 year
Secondary	metastasis	any nodular occurence keeping away from the ablation zone during the follow-up	5 year
Secondary	complication	numbers of participants with side effect and major complications	5 year