<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/NCT01699347</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-11-0059-CTIL</org_study_id>
    <nct_id>NCT01699347</nct_id>
  </id_info>
  <brief_title>Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432</brief_title>
  <acronym>OK432</acronym>
  <official_title>Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head&#xD;
      and neck region.&#xD;
&#xD;
      The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood&#xD;
      tests.&#xD;
&#xD;
      The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up&#xD;
      will be of short term - till 30 days post injection and long term - follow-up wil be till 2&#xD;
      years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cohort study, before the injection all the patients in the study will go through:&#xD;
&#xD;
        1. CT/MRI&#xD;
&#xD;
        2. US to estimate the cyst size&#xD;
&#xD;
        3. CBC, PT, PTT, INR, ASLO&#xD;
&#xD;
        4. ECG If the patient is qualified to the study the parent will sign on the inform consent,&#xD;
           than the child will be photographed AP and lateral.&#xD;
&#xD;
      The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the&#xD;
      cyst contents will be sucked than the OK432 will be injected in.&#xD;
&#xD;
      After the injection the child will stay for one night if it was general anesthesia and 4&#xD;
      hours in the case of local anesthesia.&#xD;
&#xD;
      Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US,&#xD;
      stills photo.&#xD;
&#xD;
      Long term follow-up: 6 months, 1 year, 2 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence</measure>
    <time_frame>4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TREATMENT SAFETY BY no. of participants with adverse events</measure>
    <time_frame>4 YEARS</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>CYSTIC MALFORMATION</condition>
  <arm_group>
    <arm_group_label>OK432</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intracystic injection of OK432 under US guiding</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intracystic injection of OK432 under US guiding</intervention_name>
    <description>Intracystic injection of OK432 under US guiding</description>
    <arm_group_label>OK432</arm_group_label>
    <other_name>OK432 (Picibanil)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.&#xD;
&#xD;
          -  ONLY IN THE HEAD AND NECK AREA&#xD;
&#xD;
          -  TIME FROM OPERATION AT LEAST 6 MONTHS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  penicillin allergy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  familial history of RF&#xD;
&#xD;
          -  Post streptococcal glomerulonephritis&#xD;
&#xD;
          -  Background illness-heart, kidney, lungs&#xD;
&#xD;
          -  fever &gt; 38.5c in the op day&#xD;
&#xD;
          -  URT Infection&#xD;
&#xD;
          -  Family history of PANDAS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raanan Cohen-Kerem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carmel Medical Center, Haifa, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Otolaryngology, Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raanan Cohen-Kerem, MD</last_name>
      <phone>+97248250279</phone>
      <email>raanan@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Raanan Cohen-Kerem, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>November 28, 2013</last_update_submitted>
  <last_update_submitted_qc>November 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OK432, CYSTIC MALFORMATION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Picibanil</mesh_term>
  </intervention_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/NCT01699347
org study id: CMC-11-0059-CTIL
nct id: NCT01699347
lead sponsor: 
has dmc: Yes
Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head
      and neck region.

      The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood
      tests.

      The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up
      will be of short term - till 30 days post injection and long term - follow-up wil be till 2
      years.
A cohort study, before the injection all the patients in the study will go through:

        1. CT/MRI

        2. US to estimate the cyst size

        3. CBC, PT, PTT, INR, ASLO

        4. ECG If the patient is qualified to the study the parent will sign on the inform consent,
           than the child will be photographed AP and lateral.

      The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the
      cyst contents will be sucked than the OK432 will be injected in.

      After the injection the child will stay for one night if it was general anesthesia and 4
      hours in the case of local anesthesia.

      Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US,
      stills photo.

      Long term follow-up: 6 months, 1 year, 2 years
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
time frame: 4 years
measure: TREATMENT SAFETY BY no. of participants with adverse events
time frame: 4 YEARS
arm group label: OK432
arm group type: Experimental
description: Intracystic injection of OK432 under US guiding
intervention type: Drug
intervention name: Intracystic injection of OK432 under US guiding
description: Intracystic injection of OK432 under US guiding
arm group label: OK432
other name: OK432 (Picibanil)
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Raanan Cohen-Kerem, MD
role: Principal Investigator
affiliation: Carmel Medical Center, Haifa, Israel
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Congenital Abnormalities
mesh term: Picibanil