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Comparison of Microwave Ablation With Cryoablation for Breast Tumor

Primary Purpose

Breast Tumor, Microwave Ablation, Cryoablation

Status
Unknown status
Phase
Not Applicable
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 Breast Tumor

Eligibility Criteria

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

Inclusion Criteria:

  • (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis.

Exclusion Criteria:

  • (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microwave ablation

cryoablation

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.

Clinically, cryosurgery is accomplished by placing a cryoprobe(up to 3.5 mm) through a stab incision into the tumor under ultrasound guidance.Liquid nitrogen is utilized under low operating pressure as cryogen which is controlled by the computer modulated cryogen regulator. The cryoprobe achieves rapid freezing by means of an active freeze zone at its distal tip.

Outcomes

Primary Outcome Measures

volume reduce rate
divide the volume of ablation zone by unablated lesion volume
overall survival

Secondary Outcome Measures

local tumor progress
any nodular occurence adjacent to the ablation zone during the follow-up
metastasis
any nodular occurence keeping away from the ablation zone during the follow-up
complication
numbers of participants with side effect and major complications

Full Information

First Posted
August 8, 2017
Last Updated
September 15, 2017
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03286413
Brief Title
Comparison of Microwave Ablation With Cryoablation for Breast Tumor
Official Title
Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (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 cryoablation of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed Description
A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in two centers of China will be recruited in this study and underwent US-guided percutaneous MWA and cryoablation 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, Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (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
cryoablation
Arm Type
Active Comparator
Arm Description
Clinically, cryosurgery is accomplished by placing a cryoprobe(up to 3.5 mm) through a stab incision into the tumor under ultrasound guidance.Liquid nitrogen is utilized under low operating pressure as cryogen which is controlled by the computer modulated cryogen regulator. The cryoprobe achieves rapid freezing by means of an active freeze zone at its distal tip.
Intervention Type
Procedure
Intervention Name(s)
microwave ablation
Other Intervention Name(s)
cryoablation
Intervention Description
Microwave ablation and cryoablation are both thermal ablation techniques for minimally invasive treatment of breast tumor. They are performed percutaneously by ultrasound guidance.The tumor can be completely killed without injurying adjacent tissue.
Primary Outcome Measure Information:
Title
volume reduce rate
Description
divide the volume of ablation zone by unablated lesion volume
Time Frame
3 year
Title
overall survival
Time Frame
5 year
Secondary Outcome Measure Information:
Title
local tumor progress
Description
any nodular occurence adjacent to the ablation zone during the follow-up
Time Frame
5 year
Title
metastasis
Description
any nodular occurence keeping away from the ablation zone during the follow-up
Time Frame
5 year
Title
complication
Description
numbers of participants with side effect and major complications
Time Frame
5 year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis. Exclusion Criteria: (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Yu, Dr.
Phone
66937981
Email
yu-jie301@hotmail.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
8610-66939530
Email
yu-jie301@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Microwave Ablation With Cryoablation for Breast Tumor

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