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Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Primary Purpose

Breast Tumor, Microwave Ablation, Breast Conserving Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microwave ablation
breast conserving surgery
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Tumor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. women,
  2. with invasive ductal carcinoma of the breast according to core-needle
  3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
  4. located at least 10 mm from the skin surface and chest wall.

Exclusion Criteria:

  1. men
  2. women who were pregnant or breastfeeding
  3. radiologic suspicion of multifocality or extensive intraductal carcinoma
  4. histologic diagnosis of lobular carcinoma
  5. neoadjuvant therapy
  6. previous surgery or radiation therapy of the ipsilateral breast.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microwave ablation

breast conserving surgery

Arm Description

Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm.

Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer.

Outcomes

Primary Outcome Measures

overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）

Secondary Outcome Measures

local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment
Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient

Full Information

First Posted
September 27, 2020
Last Updated
October 19, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04626986
Brief Title
Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor
Official Title
Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed Description
A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Tumor, Microwave Ablation, Breast Conserving Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microwave ablation
Arm Type
Experimental
Arm Description
Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm.
Arm Title
breast conserving surgery
Arm Type
Active Comparator
Arm Description
Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer.
Intervention Type
Procedure
Intervention Name(s)
microwave ablation
Intervention Description
Microwave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer.
Intervention Type
Procedure
Intervention Name(s)
breast conserving surgery
Intervention Description
The treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer.
Primary Outcome Measure Information:
Title
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Description
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Time Frame
5 years
Title
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Description
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Time Frame
3 years
Secondary Outcome Measure Information:
Title
local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment
Description
Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
Time Frame
5 years
Title
metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Description
Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient
Time Frame
5 years
Title
complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Description
Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women, with invasive ductal carcinoma of the breast according to core-needle tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 ) located at least 10 mm from the skin surface and chest wall. Exclusion Criteria: men women who were pregnant or breastfeeding radiologic suspicion of multifocality or extensive intraductal carcinoma histologic diagnosis of lobular carcinoma neoadjuvant therapy previous surgery or radiation therapy of the ipsilateral breast.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Yu, Dr.
Phone
66937981
Email
jiemi301@163.com
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
8601066939530
Email
jiemi301@163.com

12. IPD Sharing Statement

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Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

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