- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286413
Comparison of Microwave Ablation With Cryoablation for Breast Tumor
September 15, 2017 updated by: Ping Liang, Chinese PLA General Hospital
Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: microwave ablation
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.
|
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.
Other Names:
|
Active Comparator: cryoablation
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 5 year
|
5 year
|
|
volume reduce rate
Time Frame: 3 year
|
divide the volume of ablation zone by unablated lesion volume
|
3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local tumor progress
Time Frame: 5 year
|
any nodular occurence adjacent to the ablation zone during the follow-up
|
5 year
|
metastasis
Time Frame: 5 year
|
any nodular occurence keeping away from the ablation zone during the follow-up
|
5 year
|
complication
Time Frame: 5 year
|
numbers of participants with side effect and major complications
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
September 15, 2017
First Posted (Actual)
September 18, 2017
Study Record Updates
Last Update Posted (Actual)
September 18, 2017
Last Update Submitted That Met QC Criteria
September 15, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66939530yj
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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