<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/NCT01664936</url>
  </required_header>
  <id_info>
    <org_study_id>12-050</org_study_id>
    <nct_id>NCT01664936</nct_id>
  </id_info>
  <brief_title>Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes</brief_title>
  <official_title>Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence&#xD;
      or effect that is used with a standard clinical PET/CT and/or investigation scans can be done&#xD;
      in order to capture tumor sizes. The investigators believe endoscopies and surgical&#xD;
      procedures could benefit from this type of imaging in the future. The Cerenkov imaging could&#xD;
      be used as a guide for surgical resections.&#xD;
&#xD;
      The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or&#xD;
      other investigational tracers to image tumors and its sizes in the head, neck, breast,&#xD;
      axillary and pelvic regions with a highly sensitive camera. The investigators will be trying&#xD;
      to see if we can get another picture of the tumor using the Cerenkov light as part of the&#xD;
      standard clinical scan or therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2012</start_date>
  <completion_date type="Actual">April 3, 2018</completion_date>
  <primary_completion_date type="Actual">April 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>feasibility of clinical Cerenkov imaging</measure>
    <time_frame>2 years</time_frame>
    <description>is to assess the feasibility of clinical Cerenkov luminescence imaging using current clinical radiotracers (18F-FDG and 131I) and a highly sensitive camera.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate Cerenkov imaging</measure>
    <time_frame>2 years</time_frame>
    <description>signal with uptake of the radiotracer. Cerenkov images will be correlated with images obtained from standard clinical PET/CT and scintigraphy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Head and Neck Cancers</condition>
  <arm_group>
    <arm_group_label>pts receiving a PET/CT scan with Metastatic LNs</arm_group_label>
    <description>This study seeks to optically image the Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I in a cohort of patients with primary tumor sites and from pathologic lymph nodes after routine 18F-FDG PET 31I radiotherapy and/or investigational study scans. We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I</intervention_name>
    <description>We will image (i) patients who are receiving a PET/CT scan for tumors in the head / neck region and (ii) patients with thyroid cancer after 131I radioablation. Two scans will be completed per patient, one of the primary tumors, as well as a 'background' scan of the contralateral side or, if tumor is there as well, of the forearm. The device to be used is an intensified charge-coupled device camera (Stanford Photonics, Palo Alto, CA) connected to a laptop PC. The camera will use a Quartz high-UV transmission 50 mm 0.8f lens. The Imaging device will be placed approximately 5 cm from the area of the patient to be imaged.</description>
    <arm_group_label>pts receiving a PET/CT scan with Metastatic LNs</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        MSKCC Clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is 18 years of age or older.&#xD;
&#xD;
          -  Participant is scheduled for standard clinical and/or investigational PET/CT scan or&#xD;
             131I therapy within the Nuclear Medicine Service at Main Hospital.&#xD;
&#xD;
          -  Patients must have had pathologic lymph node metastases in the neck, axillary or&#xD;
             inguinal area (do not need to be biopsy proven) from either leukemias, lymphomas: ,&#xD;
             Head and Neck cancers (e.g. tonsillar, nasopharynx, tongue carcinoma, breast cancer or&#xD;
             melanoma;or lymphoma or tonsillar or squamous cell carcinoma with metastases in the&#xD;
             neck region for PET/CT imaging, or thyroid cancer for thyroid ablation therapy. Any&#xD;
             other more infrequent cancer metastasizing with nodal metastasis in the neck, axilla&#xD;
             and inguinal regions to cervical lymph nodes is eligible as well as the primary goal&#xD;
             is to image pathological (i.e. hypermetabolic) lymph nodes.&#xD;
&#xD;
          -  Patients with hypermetabolic activity and uptake in the neck,axilla, breast and&#xD;
             inguinal region on scan, defined visually as significant lesion suspicious for&#xD;
             malignancy by a nuclear medicine physician or trainee. (We will include a subset of&#xD;
             patients with normal lymph nodes during screening. This subset of patients will be&#xD;
             imaged as a negative control for this study.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients imaged for Cerenkov luminescence are going to be required to be in a darkened&#xD;
             enclosure for at least 10 minutes and sit still during image acquisition, potentially&#xD;
             covered by a dark cloth in case that the ambient light level remains too high for the&#xD;
             ultra-sensitive camera. Any conditions that would prevent this will exclude the&#xD;
             patients.&#xD;
&#xD;
          -  There are any other past medical, physiological or demographic concerns. This includes&#xD;
             any patients with skin blemishes that are present at the dermis over the tumor, as&#xD;
             these are of particular interest for use of this technique.&#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>Jan Grimm, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan-Kettering Cancer Center</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>18F-FDG PET/CT scan</keyword>
  <keyword>131I therapy</keyword>
  <keyword>Cerenkov Luminescence Imaging</keyword>
  <keyword>12-050</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Metastatic Lymph Nodes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</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/NCT01664936
org study id: 12-050
nct id: NCT01664936
lead sponsor: 
collaborator: 
The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence
      or effect that is used with a standard clinical PET/CT and/or investigation scans can be done
      in order to capture tumor sizes. The investigators believe endoscopies and surgical
      procedures could benefit from this type of imaging in the future. The Cerenkov imaging could
      be used as a guide for surgical resections.

      The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or
      other investigational tracers to image tumors and its sizes in the head, neck, breast,
      axillary and pelvic regions with a highly sensitive camera. The investigators will be trying
      to see if we can get another picture of the tumor using the Cerenkov light as part of the
      standard clinical scan or therapy.
observational model: Cohort
time perspective: Prospective
measure: feasibility of clinical Cerenkov imaging
time frame: 2 years
description: is to assess the feasibility of clinical Cerenkov luminescence imaging using current clinical radiotracers (18F-FDG and 131I) and a highly sensitive camera.
measure: Correlate Cerenkov imaging
time frame: 2 years
description: signal with uptake of the radiotracer. Cerenkov images will be correlated with images obtained from standard clinical PET/CT and scintigraphy.
arm group label: pts receiving a PET/CT scan with Metastatic LNs
description: This study seeks to optically image the Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I in a cohort of patients with primary tumor sites and from pathologic lymph nodes after routine 18F-FDG PET 31I radiotherapy and/or investigational study scans. We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study.
intervention type: Radiation
intervention name: Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I
description: We will image (i) patients who are receiving a PET/CT scan for tumors in the head / neck region and (ii) patients with thyroid cancer after 131I radioablation. Two scans will be completed per patient, one of the primary tumors, as well as a 'background' scan of the contralateral side or, if tumor is there as well, of the forearm. The device to be used is an intensified charge-coupled device camera (Stanford Photonics, Palo Alto, CA) connected to a laptop PC. The camera will use a Quartz high-UV transmission 50 mm 0.8f lens. The Imaging device will be placed approximately 5 cm from the area of the patient to be imaged.
arm group label: pts receiving a PET/CT scan with Metastatic LNs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Grimm, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan-Kettering Cancer Center
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Fluorodeoxyglucose F18