xml: <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/NCT06014229</url>
    </required_header>
    <id_info>
      <org_study_id>5.712.194</org_study_id>
      <nct_id>NCT06014229</nct_id>
    </id_info>
    <brief_title>Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study</brief_title>
    <official_title>Thermal Ablation of Benign Thyroid Nodules With Cryoablation or Radiofrequency</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sao Paulo General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the clinical response and safety of ultrasound guided percutaneous&#xD;
        cryoablation and a radiofrequency ablation in the treatment of benign thyroid nodules as an&#xD;
        alternative to the surgery. Ablation of benign thyroid nodules with cryoablation will be&#xD;
        directed to patients with benign thyroid lesions (two benign cytological examinations)&#xD;
        measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must&#xD;
        present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the&#xD;
        normal range values, with no signs of thyroiditis by serum antibodies over 100% of the&#xD;
        standard values; calcitonin levels in the normal range values. The cryoablation or RFA will&#xD;
        be directed in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will&#xD;
        be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6&#xD;
        and 12 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes&#xD;
        more common when the thyroid is examined by ultrasound. The vast majority of nodules are&#xD;
        benign and, over time, do not change considerably in size. The main treatment indications for&#xD;
        a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression&#xD;
        of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after&#xD;
        aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and&#xD;
        patient anxiety about the lump. The main therapeutic options are surgery (unilateral&#xD;
        lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment&#xD;
        option for solid thyroid lesions, with extensive reports in the medical literature on safety&#xD;
        and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10&#xD;
        years). In our country, several radiofrequency thermal ablation (RFA) devices are available&#xD;
        for use in the treatment of benign thyroid nodules, although some ablation devices do not&#xD;
        have the manufacturer's registration for this purpose. Additionally, there is no record in&#xD;
        the medical literature of the use of cryoablation devices for the ablation of benign thyroid&#xD;
        nodules, although they are used for the treatment of tumor lesions in different sites&#xD;
        (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is&#xD;
        to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of&#xD;
        benign thyroid nodules. Additionally, the same evaluation is possible using an RFA device not&#xD;
        yet tested for this purpose.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>
      <intervention_model_description>pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>evaluation of technical feasibility</measure>
      <time_frame>immediately after ablation</time_frame>
      <description>Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules</measure>
      <time_frame>up to 4 weeks after ablation</time_frame>
      <description>Evaluation of minor and major complication rates, immediately after and 1 month after ablation [designed as a safety measure: yes]. The safety endpoint for this study is to evaluate the incidence and severity of the procedure or device-related adverse events, as reported by the CTCAE V5.2017.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of technical success</measure>
      <time_frame>ultrasound examinations 1, 3, 6 and 12 months after ablation</time_frame>
      <description>Technical success is defined as to achieve a nodular volume ablation of 50% at 12-month follow up compared to baseline. Nodule volume measurement is performed with the ellipsoid formula: length x width x depth x 0.524.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Benign Thyroid Nodule</condition>
    <arm_group>
      <arm_group_label>Cryoablation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radiofrequency</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single session with an RF device; an antenna will be used for the treatments; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cryoablation</intervention_name>
      <description>Single session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;</description>
      <arm_group_label>Cryoablation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>radiofrequency ablation</intervention_name>
      <description>Single session with a radio frequency ablation device; an specific applicator will be used for the treatments; high impedance rates for RFA with moving-shot technique; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;</description>
      <arm_group_label>Radiofrequency</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Patients with solitary or dominant nodules with two consecutive fine needle aspiration&#xD;
               biopsy (FNAb)-proven benign in the last 12 months&#xD;
  &#xD;
            -  Thyroid nodules should be solid or almost solid (less than 40% of liquid component)&#xD;
               with volume between 5 and 65 cc;&#xD;
  &#xD;
            -  Patients considered high surgical risk candidates or patients are eligible to surgery&#xD;
               who are informed about the ablation therapy and prefers it instead surgery;&#xD;
  &#xD;
            -  Calcitonin, thyroglobulin or TSH serum levels in the normal range values&#xD;
  &#xD;
            -  No thyroid autoimmune signs on ultrasound or by autoantibody levels above 100% of the&#xD;
               standard levels&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age under 18 years&#xD;
  &#xD;
            -  Extensive goiter&#xD;
  &#xD;
            -  Predominantly cystic nodule with small solid remnant (less than 10%)&#xD;
  &#xD;
            -  Hyperfunctioning nodules (confirmed by scintigraphy)&#xD;
  &#xD;
            -  Nodule volume &gt; 65 cc&#xD;
  &#xD;
            -  TSH levels above the normal range&#xD;
  &#xD;
            -  Auto-immune treatment / thyroiditis&#xD;
  &#xD;
            -  Uncorrectable coagulopathy / impossibility to interrupt anticoagulants;&#xD;
  &#xD;
            -  Malignant or suspected malignant cytologic specimens;&#xD;
  &#xD;
            -  Pregnancy or breast-feeding;&#xD;
  &#xD;
            -  Anaplastic or poor-differentiated thyroid carcinoma;&#xD;
  &#xD;
            -  Partial thyroidectomy&#xD;
  &#xD;
            -  Asymptomatic patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ricardo Freitas, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Freitas</last_name>
      <phone>55 11 2661-7861</phone>
      <email>ricardo.freitas@hc.fm.usp.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sakamoto</last_name>
      <phone>55 11 2661-7861</phone>
      <email>denise.sakamoto@hc.fm.usp.br</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Sao Paulo General Hospital</name>
        <address>
          <city>São Paulo</city>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Denise Sakamoto</last_name>
        <phone>55 11 2661 7861</phone>
        <email>denise.sakamoto@hc.fm.usp.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Nodule</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014229
  org study id: 5.712.194
  nct id: NCT06014229
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study will evaluate the clinical response and safety of ultrasound guided percutaneous
        cryoablation and a radiofrequency ablation in the treatment of benign thyroid nodules as an
        alternative to the surgery. Ablation of benign thyroid nodules with cryoablation will be
        directed to patients with benign thyroid lesions (two benign cytological examinations)
        measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must
        present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the
        normal range values, with no signs of thyroiditis by serum antibodies over 100% of the
        standard values; calcitonin levels in the normal range values. The cryoablation or RFA will
        be directed in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will
        be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6
        and 12 months.
  Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes
        more common when the thyroid is examined by ultrasound. The vast majority of nodules are
        benign and, over time, do not change considerably in size. The main treatment indications for
        a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression
        of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after
        aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and
        patient anxiety about the lump. The main therapeutic options are surgery (unilateral
        lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment
        option for solid thyroid lesions, with extensive reports in the medical literature on safety
        and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10
        years). In our country, several radiofrequency thermal ablation (RFA) devices are available
        for use in the treatment of benign thyroid nodules, although some ablation devices do not
        have the manufacturer's registration for this purpose. Additionally, there is no record in
        the medical literature of the use of cryoablation devices for the ablation of benign thyroid
        nodules, although they are used for the treatment of tumor lesions in different sites
        (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is
        to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of
        benign thyroid nodules. Additionally, the same evaluation is possible using an RFA device not
        yet tested for this purpose.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: pilot study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: evaluation of technical feasibility
  time frame: immediately after ablation
  description: Defined as the ability to puncture the nodule and perform the ablation as preoperatively planned.
  measure: 2) Incidence of adverse events secondary to the treatment (safety and tolerability) of thermal ablation of benign thyroid nodules
  time frame: up to 4 weeks after ablation
  description: Evaluation of minor and major complication rates, immediately after and 1 month after ablation [designed as a safety measure: yes]. The safety endpoint for this study is to evaluate the incidence and severity of the procedure or device-related adverse events, as reported by the CTCAE V5.2017.
  measure: Evaluation of technical success
  time frame: ultrasound examinations 1, 3, 6 and 12 months after ablation
  description: Technical success is defined as to achieve a nodular volume ablation of 50% at 12-month follow up compared to baseline. Nodule volume measurement is performed with the ellipsoid formula: length x width x depth x 0.524.
  arm group label: Cryoablation
  arm group type: Experimental
  description: Device: Cryoablation Single session with an argon-based device; a V-probe 17-G applicator will be used for the treatments; gas release 100%; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
  arm group label: Radiofrequency
  arm group type: Experimental
  description: Single session with an RF device; an antenna will be used for the treatments; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
  intervention type: Device
  intervention name: cryoablation
  description: Single session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
  arm group label: Cryoablation
  intervention type: Device
  intervention name: radiofrequency ablation
  description: Single session with a radio frequency ablation device; an specific applicator will be used for the treatments; high impedance rates for RFA with moving-shot technique; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
  arm group label: Radiofrequency
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ricardo Freitas, MD, PhD
  role: Principal Investigator
  affiliation: Instituto de Radiologia - Hospital das Clínicas da Universidade de São Paulo
  last name: Freitas
  phone: 55 11 2661-7861
  email: ricardo.freitas@hc.fm.usp.br
  last name: Sakamoto
  phone: 55 11 2661-7861
  email: denise.sakamoto@hc.fm.usp.br
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Thyroid Nodule
  mesh term: Thyroid Diseases
  sharing ipd: No