<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/NCT04492735</url>
  </required_header>
  <id_info>
    <org_study_id>PSORC ICG</org_study_id>
    <nct_id>NCT04492735</nct_id>
  </id_info>
  <brief_title>The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies</brief_title>
  <official_title>The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roshni Dasgupta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</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>
      Use of indocyanine green will augment the accuracy of identification and resection of both&#xD;
      primary solid malignancies as well as their pulmonary metastases, where applicable We will&#xD;
      conduct a prospective feasibility study of pediatric patients with solid malignancies with or&#xD;
      without lung metastatases who present at the time of initial diagnosis or relapse. These&#xD;
      patients will receive a targeted dye to aid in the resection of these metastases. We plan to&#xD;
      assess ICG as it relates to:&#xD;
&#xD;
        1. Diagnostic accuracy using pathologic correlation as gold standard measure&#xD;
&#xD;
        2. Short and long term event free and overall survival&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with solid malignancies or metastatic lesions who require clinically&#xD;
      indicated resection will be identified by their Oncologist. The oncologist will inform the&#xD;
      subject/family about the study and ask if they may be interested in participating. If the&#xD;
      subject/family demonstrates potential interest in the study, the Pediatric Surgery Research&#xD;
      team will discuss the risks and benefits of pre-operative ICG administration with the&#xD;
      patients and enrollment.&#xD;
&#xD;
      Study subjects: All patients diagnosed with solid malignancies as well as those with&#xD;
      metastatic disease distant from the primary tumor will be potentially eligible for the study.&#xD;
      Diagnosis will be made:&#xD;
&#xD;
        1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI,&#xD;
           CT scan, etc), and sometimes biopsy.&#xD;
&#xD;
        2. Prior to definitive surgical resection of the newly diagnosed malignancy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy using pathologic correlation as gold standard measure</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Short and long term event free and overall survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Metastatic Disease</condition>
  <condition>Primary Tumor</condition>
  <condition>Solid Malignancies</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Oncology solid, primary malignancies or their related metastatic lesion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients with newly diagnosed solid, primary malignancies or their related metastatic&#xD;
        lesions.&#xD;
&#xD;
        Diagnosis of primary or metastatic malignancy will be made by combination of:&#xD;
&#xD;
          1. Clinical evaluation and physical exam&#xD;
&#xD;
          2. Radiologic study including ultrasound, CT scan, and/or MRI&#xD;
&#xD;
          3. Pathologic diagnosis after biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those patients and parents/guardians unwilling to provide consent/assent.&#xD;
&#xD;
          2. Pregnant and/or women who are breast feeding.&#xD;
&#xD;
          3. Patients with Iodine allergies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Erin Watters</last_name>
    <phone>513-803-7024</phone>
    <email>erin.watters@cchmc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Watters</last_name>
      <phone>513-803-7024</phone>
      <email>erin.watters@cchmc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Medical Center, Cincinnati</investigator_affiliation>
    <investigator_full_name>Roshni Dasgupta</investigator_full_name>
    <investigator_title>Roshni Dasgupta, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04492735
org study id: PSORC ICG
nct id: NCT04492735
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Use of indocyanine green will augment the accuracy of identification and resection of both
      primary solid malignancies as well as their pulmonary metastases, where applicable We will
      conduct a prospective feasibility study of pediatric patients with solid malignancies with or
      without lung metastatases who present at the time of initial diagnosis or relapse. These
      patients will receive a targeted dye to aid in the resection of these metastases. We plan to
      assess ICG as it relates to:

        1. Diagnostic accuracy using pathologic correlation as gold standard measure

        2. Short and long term event free and overall survival
Patients diagnosed with solid malignancies or metastatic lesions who require clinically
      indicated resection will be identified by their Oncologist. The oncologist will inform the
      subject/family about the study and ask if they may be interested in participating. If the
      subject/family demonstrates potential interest in the study, the Pediatric Surgery Research
      team will discuss the risks and benefits of pre-operative ICG administration with the
      patients and enrollment.

      Study subjects: All patients diagnosed with solid malignancies as well as those with
      metastatic disease distant from the primary tumor will be potentially eligible for the study.
      Diagnosis will be made:

        1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI,
           CT scan, etc), and sometimes biopsy.

        2. Prior to definitive surgical resection of the newly diagnosed malignancy
observational model: Case-Only
time perspective: Prospective
measure: Diagnostic accuracy using pathologic correlation as gold standard measure
time frame: 2 years
measure: Short and long term event free and overall survival
time frame: 2 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 45 Years
healthy volunteers: No
last name: Erin Watters
phone: 513-803-7024
email: erin.watters@cchmc.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's Hospital Medical Center, Cincinnati
investigator full name: Roshni Dasgupta
investigator title: Roshni Dasgupta, MD
mesh term: Neoplasms
mesh term: Neoplasm Metastasis
sharing ipd: Undecided