<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286413</url>
  </required_header>
  <id_info>
    <org_study_id>66939530yj</org_study_id>
    <nct_id>NCT03286413</nct_id>
  </id_info>
  <brief_title>Comparison of Microwave Ablation With Cryoablation for Breast Tumor</brief_title>
  <official_title>Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will perform this study to prospectively compare the clinical outcome after&#xD;
      percutaneous microwave ablation(MWA) and cryoablation of benign and malignant breast lesion&#xD;
      under ultrasound (US) guidance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with&#xD;
      malignant breast lesions in two centers of China will be recruited in this study and&#xD;
      underwent US-guided percutaneous MWA and cryoablation treatment. Information for each patient&#xD;
      includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type;&#xD;
      location of tumor according to whether adjacent to skin, pectoralis, areola and papilla.&#xD;
      Ablation variables including session, puncture, time, and power; complete ablation,&#xD;
      complications; reduction in volume, palpability, pain and cosmetic satisfying&#xD;
      outcomes,recurrence,survival will be compared and analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>volume reduce rate</measure>
    <time_frame>3 year</time_frame>
    <description>divide the volume of ablation zone by unablated lesion volume</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>local tumor progress</measure>
    <time_frame>5 year</time_frame>
    <description>any nodular occurence adjacent to the ablation zone during the follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metastasis</measure>
    <time_frame>5 year</time_frame>
    <description>any nodular occurence keeping away from the ablation zone during the follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>5 year</time_frame>
    <description>numbers of participants with side effect and major complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Breast Tumor</condition>
  <condition>Microwave Ablation</condition>
  <condition>Cryoablation</condition>
  <arm_group>
    <arm_group_label>microwave ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cryoablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>microwave ablation</intervention_name>
    <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.</description>
    <arm_group_label>cryoablation</arm_group_label>
    <arm_group_label>microwave ablation</arm_group_label>
    <other_name>cryoablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy;&#xD;
             (b) for the benign lesion, continually increasing during a half year followup,with the&#xD;
             symptoms of local pain, discomfortable or compression considered probably relating to&#xD;
             the mass of breast; the patient with evidently psychological pressure due to the&#xD;
             occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant&#xD;
             lesion, with the tumor size smaller than 2cm and without other metastasis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence&#xD;
             of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c)&#xD;
             the patients during menstrual period; (d) the patients referring to other therapies&#xD;
             including surgical excision and vacuum-assisted biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jie Yu, Dr.</last_name>
    <phone>66937981</phone>
    <email>yu-jie301@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Yu, Doctor</last_name>
      <phone>8610-66939530</phone>
      <email>yu-jie301@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Ping Liang</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286413
org study id: 66939530yj
nct id: NCT03286413
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: volume reduce rate
time frame: 3 year
description: divide the volume of ablation zone by unablated lesion volume
measure: overall survival
time frame: 5 year
measure: local tumor progress
time frame: 5 year
description: any nodular occurence adjacent to the ablation zone during the follow-up
measure: metastasis
time frame: 5 year
description: any nodular occurence keeping away from the ablation zone during the follow-up
measure: complication
time frame: 5 year
description: numbers of participants with side effect and major complications
arm group label: microwave ablation
arm group type: Experimental
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 group label: cryoablation
arm group type: Active Comparator
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: microwave ablation
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.
arm group label: cryoablation
arm group label: microwave ablation
other name: cryoablation
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jie Yu, Dr.
phone: 66937981
email: yu-jie301@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Ping Liang
investigator title: Prof.
mesh term: Breast Neoplasms