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Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860104
Recruitment Status : Unknown
Verified November 2016 by Ping Liang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Neoplasm of Breast Device: microwave ablation Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
microwave ablation
microwave ablation
Device: microwave ablation
ultrasound guided percutaneous microwave ablation for breast lesions




Primary Outcome Measures :
  1. reduction in volume [ Time Frame: 5 year ]
    the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860104


Contacts
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Contact: Jie Yu, Doctor 8610-66939530 yu-jie301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jie Yu, Doctor    8610-66939530    yu-jie301@hotmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Ping Liang, Doctor Chinese PLA General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ping Liang, Chair, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02860104    
Other Study ID Numbers: 939530lp
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: cosmetics effect, volume reduction rate,complications
Keywords provided by Ping Liang, Chinese PLA General Hospital:
microwave ablation
breast
multicenter
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases