Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

NCT02860104 | Unknown Phase 2 DMC

• 1 other identifier: 939530lp
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm of Breast

Keywords

microwave ablation; breast; multicenter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

microwave ablation

OTHER

microwave ablation

Device: microwave ablation

Interventions

microwave ablation DEVICE

ultrasound guided percutaneous microwave ablation for breast lesions

microwave ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 32356159 DERIVED

• 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.

  PMID: 31179781 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ping Liang, Doctor

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Jie Yu, Doctor

CONTACT

8610-66939530; yu-jie301@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 9, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)