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Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

Primary Purpose

Neoplasm of Breast

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
microwave ablation
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm of Breast focused on measuring microwave ablation, breast, multicenter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

microwave ablation

Arm Description

microwave ablation

Outcomes

Primary Outcome Measures

reduction in volume
the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
November 22, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02860104
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Breast
Keywords
microwave ablation, breast, multicenter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microwave ablation
Arm Type
Other
Arm Description
microwave ablation
Intervention Type
Device
Intervention Name(s)
microwave ablation
Intervention Description
ultrasound guided percutaneous microwave ablation for breast lesions
Primary Outcome Measure Information:
Title
reduction in volume
Description
the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = [(initial volume - final volume) × 100]/initial volume.
Time Frame
5 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Yu, Doctor
Phone
8610-66939530
Email
yu-jie301@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liang, Doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Yu, Doctor
Phone
8610-66939530
Email
yu-jie301@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
cosmetics effect, volume reduction rate,complications
Citations:
PubMed Identifier
32356159
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.
Results Reference
derived
PubMed Identifier
31179781
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.
Results Reference
derived

Learn more about this trial

Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

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