<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/NCT01677975</url>
  </required_header>
  <id_info>
    <org_study_id>Ultrasound in melanomas</org_study_id>
    <nct_id>NCT01677975</nct_id>
  </id_info>
  <brief_title>The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal with this study is to evaluate the value of dynamic lymphscintigraphy and&#xD;
      ultrasoundscanning preoperative in patients with melanomas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2012</start_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <number_of_arms>1</number_of_arms>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>ultrasound, dynamic lymphscintigraphy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FNA (fine needle aspiration)</intervention_name>
    <arm_group_label>ultrasound, dynamic lymphscintigraphy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with&#xD;
        ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Other malignant illness Known local, regional or non-regional metastasis on the time of&#xD;
        diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ultrasounddepartment 4123, Rigshospitalet</name>
      <address>
        <city>Blegdamsvej 9</city>
        <state>København Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Trine-Lise Lambine</investigator_full_name>
    <investigator_title>afdelingslæge</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT01677975
org study id: Ultrasound in melanomas
nct id: NCT01677975
lead sponsor: 
has dmc: No
The goal with this study is to evaluate the value of dynamic lymphscintigraphy and
      ultrasoundscanning preoperative in patients with melanomas.
arm group label: ultrasound, dynamic lymphscintigraphy
arm group type: Experimental
intervention type: Procedure
intervention name: FNA (fine needle aspiration)
arm group label: ultrasound, dynamic lymphscintigraphy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Trine-Lise Lambine
investigator title: afdelingslæge
mesh term: Melanoma