<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/NCT04437030</url>
  </required_header>
  <id_info>
    <org_study_id>MSOT HNC</org_study_id>
    <nct_id>NCT04437030</nct_id>
  </id_info>
  <brief_title>Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors</brief_title>
  <official_title>Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Heidelberg</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>
      Multispectral photoacoustic imaging enables the measurement of the optical absorption of&#xD;
      various tissue components or exogenous contrast agents in vivo. The dominant, near infrared&#xD;
      absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen,&#xD;
      melanin and lipids. The multispectral measurement of the absorption of hemoglobin shows&#xD;
      changes in blood oxygen saturation and blood volume. The high resolution of photoacoustic&#xD;
      imaging also enables the vascular structure to be displayed. The aim of this exploratory&#xD;
      study is to generate hypotheses by applying photoacoustic imaging to the field of head and&#xD;
      neck tumor therapy. The next step is to investigate whether and how photoacoustic imaging can&#xD;
      help improve diagnostics and better planning of treatments in the future. In particular, the&#xD;
      differences between normal and tumor tissue and the changes in the tissue due to radiation&#xD;
      therapy using photoacoustic imaging are examined. In the quantitative analysis of the images,&#xD;
      measured chromophores, primarily oxygen saturation, blood volume and collagen concentrations&#xD;
      at different measuring points are used in the course of the therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multispectral photoacoustics enable non-invasive, inexpensive and dose-free real-time imaging&#xD;
      of light-absorbing molecules (absorbers), e.g. Deoxyhemoglobin and oxygenated hemoglobin in&#xD;
      human tissue. This allows blood oxygen saturation (sO2) to be determined at depths of up to&#xD;
      several centimeters. Measurements of correlates to blood volume and collagen concentration&#xD;
      are also made possible. In photoacoustic imaging, the tissue to be examined is irradiated&#xD;
      with nanosecond short, near-infrared (650 - 1300nm) laser pulses. If laser light is locally&#xD;
      absorbed by a tissue structure, it expands thermoelastically, which triggers an ultrasonic&#xD;
      pressure wave, which is measured with the aid of an ultrasonic head. The initial pressure&#xD;
      distribution and thus the absorption in the tissue can then be reconstructed. Since different&#xD;
      molecules show distinct absorption behavior depending on the wavelength in the near infrared,&#xD;
      by acquiring several wavelengths it is possible to estimate which absorbers are in which&#xD;
      concentration in a tissue structure. The effectiveness and tolerability of modern&#xD;
      high-precision radiation therapy for head and neck tumors largely depends on the quality of&#xD;
      the imaging. The potential diagnostic benefits of photoacoustics in the radiotherapy of&#xD;
      patients with head and neck tumors principally concern the target volume definition, the&#xD;
      implementation of image-guided, adaptive radiotherapy and imaging tumor follow-up as well as&#xD;
      the early detection of tumors.&#xD;
&#xD;
      Multispectral photoacoustics primarily enable the analysis of tumor hypoxia, which has been&#xD;
      associated several times with increased radio resistance and an unfavorable prognosis. In&#xD;
      addition, other factors, e.g. the blood volume and the collagen content in the tissue are&#xD;
      analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>diagnostic feasibility of photoacoustic imaging: Oxygen Saturation</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>Measurement of Oxygen Saturation in the tumor tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: Oxygen Saturation</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>Measurement of Oxygen Saturation in the tumor tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: Oxygen Saturation</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>Measurement of Oxygen Saturation in the tumor tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: blood volume</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>blood volume</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: blood volume</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>blood volume</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: blood volume</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>blood volume</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: blood volume</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>amount of collagen in the tumor tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>amount of collagen in the tumor tissue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>amount of collagen in the tumor tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>Differences of Oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>Differences of Oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>Differences of Oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>blood volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>blood volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>blood volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>amount of collagen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>amount of collagen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Tumor tissue and normal tissue</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>amount of collagen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>multimodal information about tissue morphology</measure>
    <time_frame>previouse to Radiotherapy start</time_frame>
    <description>Registration of photoaccustic and MRI/CT Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>multimodal information about tissue function</measure>
    <time_frame>3 weeks after Radiotherapy start</time_frame>
    <description>Registration of photoaccustic and MRI/CT Imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>multimodal information about tissue function</measure>
    <time_frame>3 month after Radiotherapy start</time_frame>
    <description>Registration of photoaccustic and MRI/CT Imaging</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient with Head and neck cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healty subjects with not history of Tumor disease in the Head and neck region</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MSOT Acuity Echo device</intervention_name>
    <description>The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willingness and ability to participate&#xD;
&#xD;
          2. sufficient knowledge of German to understand the patient / subject information and the&#xD;
             declaration of consent,&#xD;
&#xD;
          3. tumor disease to be treated by radiotherapy in the neck and neck area,&#xD;
&#xD;
          4. Completed wound healing after operative interventions in the head and neck area,&#xD;
&#xD;
          5. The patient's consent and written consent,&#xD;
&#xD;
          6. the patient's ability to assess the nature and scope as well as possible consequences&#xD;
             of the clinical study,&#xD;
&#xD;
        8. Age ≥ 18 years.&#xD;
&#xD;
        Requirement 3 does not apply to the control group of healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-radiation in the head and neck area&#xD;
&#xD;
          -  Inadequate regression of toxicities from previous therapies&#xD;
&#xD;
          -  Indications that the participant is unlikely to adhere to the study protocol (e.g.&#xD;
             lack of compliance)&#xD;
&#xD;
          -  Missing written declaration of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Adeberg, PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Held, MD</last_name>
    <phone>06221 56</phone>
    <phone_ext>8201</phone_ext>
    <email>thomas.held@med.uni-heidelberg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adriane Hommertgen, Dr. rer. nat.</last_name>
    <phone>06221 56</phone>
    <phone_ext>8201</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hopsital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jürgen Debus, MD PhD</last_name>
      <phone>+49 6221 56</phone>
      <phone_ext>34093</phone_ext>
      <email>juergen.debus@med.uni-heidelberg.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Juergen Debus</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04437030
org study id: MSOT HNC
nct id: NCT04437030
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multispectral photoacoustic imaging enables the measurement of the optical absorption of
      various tissue components or exogenous contrast agents in vivo. The dominant, near infrared
      absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen,
      melanin and lipids. The multispectral measurement of the absorption of hemoglobin shows
      changes in blood oxygen saturation and blood volume. The high resolution of photoacoustic
      imaging also enables the vascular structure to be displayed. The aim of this exploratory
      study is to generate hypotheses by applying photoacoustic imaging to the field of head and
      neck tumor therapy. The next step is to investigate whether and how photoacoustic imaging can
      help improve diagnostics and better planning of treatments in the future. In particular, the
      differences between normal and tumor tissue and the changes in the tissue due to radiation
      therapy using photoacoustic imaging are examined. In the quantitative analysis of the images,
      measured chromophores, primarily oxygen saturation, blood volume and collagen concentrations
      at different measuring points are used in the course of the therapy.
Multispectral photoacoustics enable non-invasive, inexpensive and dose-free real-time imaging
      of light-absorbing molecules (absorbers), e.g. Deoxyhemoglobin and oxygenated hemoglobin in
      human tissue. This allows blood oxygen saturation (sO2) to be determined at depths of up to
      several centimeters. Measurements of correlates to blood volume and collagen concentration
      are also made possible. In photoacoustic imaging, the tissue to be examined is irradiated
      with nanosecond short, near-infrared (650 - 1300nm) laser pulses. If laser light is locally
      absorbed by a tissue structure, it expands thermoelastically, which triggers an ultrasonic
      pressure wave, which is measured with the aid of an ultrasonic head. The initial pressure
      distribution and thus the absorption in the tissue can then be reconstructed. Since different
      molecules show distinct absorption behavior depending on the wavelength in the near infrared,
      by acquiring several wavelengths it is possible to estimate which absorbers are in which
      concentration in a tissue structure. The effectiveness and tolerability of modern
      high-precision radiation therapy for head and neck tumors largely depends on the quality of
      the imaging. The potential diagnostic benefits of photoacoustics in the radiotherapy of
      patients with head and neck tumors principally concern the target volume definition, the
      implementation of image-guided, adaptive radiotherapy and imaging tumor follow-up as well as
      the early detection of tumors.

      Multispectral photoacoustics primarily enable the analysis of tumor hypoxia, which has been
      associated several times with increased radio resistance and an unfavorable prognosis. In
      addition, other factors, e.g. the blood volume and the collagen content in the tissue are
      analyzed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
time frame: previouse to Radiotherapy start
description: Measurement of Oxygen Saturation in the tumor tissue
measure: diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
time frame: 3 weeks after Radiotherapy start
description: Measurement of Oxygen Saturation in the tumor tissue
measure: diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
time frame: 3 month after Radiotherapy start
description: Measurement of Oxygen Saturation in the tumor tissue
measure: diagnostic feasibility of photoacoustic imaging: blood volume
time frame: previouse to Radiotherapy start
description: blood volume
measure: diagnostic feasibility of photoacoustic imaging: blood volume
time frame: 3 weeks after Radiotherapy start
description: blood volume
measure: diagnostic feasibility of photoacoustic imaging: blood volume
time frame: 3 month after Radiotherapy start
description: blood volume
measure: diagnostic feasibility of photoacoustic imaging: blood volume
time frame: previouse to Radiotherapy start
description: amount of collagen in the tumor tissue
measure: diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
time frame: 3 weeks after Radiotherapy start
description: amount of collagen in the tumor tissue
measure: diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
time frame: 3 month after Radiotherapy start
description: amount of collagen in the tumor tissue
measure: Analysis of Tumor tissue and normal tissue
time frame: previouse to Radiotherapy start
description: Differences of Oxygen saturation
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 weeks after Radiotherapy start
description: Differences of Oxygen saturation
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 month after Radiotherapy start
description: Differences of Oxygen saturation
measure: Analysis of Tumor tissue and normal tissue
time frame: previouse to Radiotherapy start
description: blood volume
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 weeks after Radiotherapy start
description: blood volume
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 month after Radiotherapy start
description: blood volume
measure: Analysis of Tumor tissue and normal tissue
time frame: previouse to Radiotherapy start
description: amount of collagen
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 weeks after Radiotherapy start
description: amount of collagen
measure: Analysis of Tumor tissue and normal tissue
time frame: 3 month after Radiotherapy start
description: amount of collagen
measure: multimodal information about tissue morphology
time frame: previouse to Radiotherapy start
description: Registration of photoaccustic and MRI/CT Imaging
measure: multimodal information about tissue function
time frame: 3 weeks after Radiotherapy start
description: Registration of photoaccustic and MRI/CT Imaging
measure: multimodal information about tissue function
time frame: 3 month after Radiotherapy start
description: Registration of photoaccustic and MRI/CT Imaging
arm group label: Patient
arm group type: Active Comparator
description: Patient with Head and neck cancer
arm group label: Healthy subjects
arm group type: Other
description: Healty subjects with not history of Tumor disease in the Head and neck region
intervention type: Device
intervention name: MSOT Acuity Echo device
description: The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
arm group label: Healthy subjects
arm group label: Patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian Adeberg, PD
role: Principal Investigator
affiliation: University Hospital Heidelberg
last name: Thomas Held, MD
phone: 06221 56
phone ext: 8201
email: thomas.held@med.uni-heidelberg.de
last name: Adriane Hommertgen, Dr. rer. nat.
phone: 06221 56
phone ext: 8201
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Juergen Debus
investigator title: Head of Department
mesh term: Head and Neck Neoplasms
sharing ipd: No