<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/NCT04498221</url>
  </required_header>
  <id_info>
    <org_study_id>127659</org_study_id>
    <nct_id>NCT04498221</nct_id>
  </id_info>
  <brief_title>Lymphatic Mapping Of Oropharyngeal Cancer</brief_title>
  <acronym>LOOC</acronym>
  <official_title>Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A multi-centre validation study to evaluate whether a new imaging and surgical protocol would&#xD;
      work as well as the current god standard in identifying sentinel nodes in patients with&#xD;
      oropharyngeal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer at the back of the mouth and throat is usually discovered after it has spread to lymph&#xD;
      glands in the neck. Treatment therefore involves dealing with both the original tumour (in&#xD;
      the mouth/throat) and the spread cancer in the lymph glands. This type of cancer sometimes&#xD;
      spreads to both sides of the neck, not just the side on which the original tumour was&#xD;
      located. The decision as to whether to treat the other side of the neck as well depends on&#xD;
      various factors including the aggressiveness of the tumour, whether the patient smokes and&#xD;
      whether or not the HPV virus is present in the tumour. This is inevitably inexact, and&#xD;
      assessing the likelihood of the cancer spreading to the other side of the neck always&#xD;
      involves an element of estimation. Some patients end up being treated unnecessarily on both&#xD;
      sides (often with severe and lasting effects on swallowing, meaning they have to use a&#xD;
      feeding tube), while others receive treatment on one side only but the cancer comes back on&#xD;
      the other side.&#xD;
&#xD;
      This study will provide more accurate information on which to base the decision as to whether&#xD;
      to treat the other side of the neck. The study will use a procedure known as sentinel node&#xD;
      biopsy (SNB) to establish (with a high degree of accuracy) whether or not the cancer has&#xD;
      spread to the other side of the neck. The study will be in two stages. The first stage is the&#xD;
      imaging stage. A radioactive substance called Lymphoseek will be injected into the tumour.&#xD;
      Lymphoseek moves quickly into the lymph nodes and can then be detected using a handheld gamma&#xD;
      camera. The first nodes that Lymphoseek moves into are the &quot;sentinel&quot; nodes. Patients already&#xD;
      undergo an examination under anaesthetic (EUA); the patients participating in the study will&#xD;
      have the Lymphoseek injected additionally and the sentinel nodes detected during this EUA.&#xD;
      The use of the handheld camera is relatively new; so, all of the patients in the study will&#xD;
      also have a CT scan the next day to double check whether the handheld camera identified the&#xD;
      sentinel nodes correctly. The second stage of the study, the surgery stage, will involve a&#xD;
      new group of patients having the imaging procedure. Those who do have sentinel nodes in the&#xD;
      other side of the neck will have them removed during the EUA. Those nodes will then be&#xD;
      examined thoroughly for signs of cancer. A separate limb of stage one of the study will&#xD;
      involve some patients whose main tumours are easily accessible also having their tumour&#xD;
      injected with Lymphoseek under local anaesthetic in an outpatient clinic. In the study this&#xD;
      will take place several days after the initial injection with Lymphoseek. If this procedure&#xD;
      is found to be acceptable to patients, it would mean that patients could have the Lymphoseek&#xD;
      injected before the EUA, thereby allowing time for the sentinel nodes to be identified by CT&#xD;
      scan so that they can be removed during the EUA. This will provide a way to ensure that, even&#xD;
      if the handheld camera cannot be used, the sentinel nodes can still be removed while the&#xD;
      patient is under anaesthetic for the EUA. If the study is successful, the patient will be&#xD;
      able to have much more accurate information about whether their cancer has, or might, spread&#xD;
      to the other side of the neck, without having to undergo an additional general anaesthetic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2022</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of contralateral drainage</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Rate of contralateral drainage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of contralateral nodes on SPECT/CT</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Number of contralateral nodes on SPECT/CT will be used as the denominator in calculating the sensitivity of fhSPECT in independently verified images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability to patients assessed by questionnaire.</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Acceptability to patients assessed by questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).</measure>
    <time_frame>24 hours post injection</time_frame>
    <description>Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Imaging Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Imaging procedure</intervention_name>
    <description>During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan</description>
    <arm_group_label>Imaging Phase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical procedure</intervention_name>
    <description>Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.</description>
    <arm_group_label>Surgical Phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 or over&#xD;
&#xD;
          -  New diagnosis of OPC - all anatomical subsites and HPV status accepted&#xD;
&#xD;
          -  Unilateral metastatic nodes equating to AJCC TNM8 clinical staging N1-N2b for P16&#xD;
             negative and N1 for P16 positive patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspicious bilateral nodes on imaging&#xD;
&#xD;
          -  Previous radiotherapy or surgery to the neck&#xD;
&#xD;
          -  Second primary oropharyngeal tumours&#xD;
&#xD;
          -  Distant metastasis (e.g. lung, bone)&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Allergy to lymphatic tracers&#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>Clare Schilling</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Trial Manager</last_name>
    <phone>02076799274</phone>
    <email>ncita.looc@ucl.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlie Mizon</last_name>
      <email>situ.looc@ucl.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 4, 2019</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</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>Oropharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No identifiable data will be shared with anyone outside the study</ipd_description>
  </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/NCT04498221
org study id: 127659
nct id: NCT04498221
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A multi-centre validation study to evaluate whether a new imaging and surgical protocol would
      work as well as the current god standard in identifying sentinel nodes in patients with
      oropharyngeal cancer.
Cancer at the back of the mouth and throat is usually discovered after it has spread to lymph
      glands in the neck. Treatment therefore involves dealing with both the original tumour (in
      the mouth/throat) and the spread cancer in the lymph glands. This type of cancer sometimes
      spreads to both sides of the neck, not just the side on which the original tumour was
      located. The decision as to whether to treat the other side of the neck as well depends on
      various factors including the aggressiveness of the tumour, whether the patient smokes and
      whether or not the HPV virus is present in the tumour. This is inevitably inexact, and
      assessing the likelihood of the cancer spreading to the other side of the neck always
      involves an element of estimation. Some patients end up being treated unnecessarily on both
      sides (often with severe and lasting effects on swallowing, meaning they have to use a
      feeding tube), while others receive treatment on one side only but the cancer comes back on
      the other side.

      This study will provide more accurate information on which to base the decision as to whether
      to treat the other side of the neck. The study will use a procedure known as sentinel node
      biopsy (SNB) to establish (with a high degree of accuracy) whether or not the cancer has
      spread to the other side of the neck. The study will be in two stages. The first stage is the
      imaging stage. A radioactive substance called Lymphoseek will be injected into the tumour.
      Lymphoseek moves quickly into the lymph nodes and can then be detected using a handheld gamma
      camera. The first nodes that Lymphoseek moves into are the "sentinel" nodes. Patients already
      undergo an examination under anaesthetic (EUA); the patients participating in the study will
      have the Lymphoseek injected additionally and the sentinel nodes detected during this EUA.
      The use of the handheld camera is relatively new; so, all of the patients in the study will
      also have a CT scan the next day to double check whether the handheld camera identified the
      sentinel nodes correctly. The second stage of the study, the surgery stage, will involve a
      new group of patients having the imaging procedure. Those who do have sentinel nodes in the
      other side of the neck will have them removed during the EUA. Those nodes will then be
      examined thoroughly for signs of cancer. A separate limb of stage one of the study will
      involve some patients whose main tumours are easily accessible also having their tumour
      injected with Lymphoseek under local anaesthetic in an outpatient clinic. In the study this
      will take place several days after the initial injection with Lymphoseek. If this procedure
      is found to be acceptable to patients, it would mean that patients could have the Lymphoseek
      injected before the EUA, thereby allowing time for the sentinel nodes to be identified by CT
      scan so that they can be removed during the EUA. This will provide a way to ensure that, even
      if the handheld camera cannot be used, the sentinel nodes can still be removed while the
      patient is under anaesthetic for the EUA. If the study is successful, the patient will be
      able to have much more accurate information about whether their cancer has, or might, spread
      to the other side of the neck, without having to undergo an additional general anaesthetic.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rate of contralateral drainage
time frame: 24 hours post injection
description: Rate of contralateral drainage
measure: Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
time frame: 24 hours post injection
description: Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
measure: Number of contralateral nodes on SPECT/CT
time frame: 24 hours post injection
description: Number of contralateral nodes on SPECT/CT will be used as the denominator in calculating the sensitivity of fhSPECT in independently verified images
measure: Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
time frame: 24 hours post injection
description: Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans.
measure: Acceptability to patients assessed by questionnaire.
time frame: 24 hours post injection
description: Acceptability to patients assessed by questionnaire.
measure: Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).
time frame: 24 hours post injection
description: Occult metastastatic rate of contralateral nodes (positive sentinel node biopsy).
arm group label: Imaging Phase
arm group type: Experimental
description: During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
arm group label: Surgical Phase
arm group type: Experimental
description: Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
intervention type: Procedure
intervention name: Imaging procedure
description: During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
arm group label: Imaging Phase
intervention type: Procedure
intervention name: Surgical procedure
description: Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
arm group label: Surgical Phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clare Schilling
role: Principal Investigator
affiliation: University College, London
last name: Trial Manager
phone: 02076799274
email: ncita.looc@ucl.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Oropharyngeal Neoplasms
sharing ipd: No
ipd description: No identifiable data will be shared with anyone outside the study