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Status unknownNCT02860104Updated Nov 23, 2016

Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

A Phase 2/3 interventional study of microwave ablation in Neoplasm of Breast, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Chinese PLA General Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neoplasm of Breast

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Keywords

  • microwave ablation
  • breast
  • multicenter
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 500 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Other
    microwave ablation

    microwave ablation

    Device: microwave ablation

Interventions

  • Devicemicrowave ablation

    ultrasound guided percutaneous microwave ablation for breast lesions

06

What researchers measure

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.

    Time frame: 5 year

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32356159 ↗
  • 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. PubMed 31179781 ↗

Individual participant data

Plan to share: Yes — cosmetics effect, volume reduction rate,complications

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02860104
Lead sponsor
Chinese PLA General Hospital
Responsible party
Ping Liang (Chair, Chinese PLA General Hospital) — Principal investigator
First posted
Aug 9, 2016
Start date
Dec 2012
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Nov 23, 2016

Study contacts

Jie Yu, Doctor
Contact
yu-jie301@hotmail.com
8610-66939530
Ping Liang, Doctor
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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