<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/NCT04428528</url>
  </required_header>
  <id_info>
    <org_study_id>456-2016</org_study_id>
    <nct_id>NCT04428528</nct_id>
  </id_info>
  <brief_title>Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy</brief_title>
  <official_title>Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Our objective in this pilot study will be to identify PA parameters that can distinguish&#xD;
      benign vs. malignant lesions, and also, if PA parameters change with within breast tumors&#xD;
      during chemotherapy treatment over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate photoacoustic tissue characteristics of breast lesions both at&#xD;
      diagnosis, and within a separate subgroup of patients, physiological changes in breast tumors&#xD;
      during neoadjuvant chemotherapy (NAC). Our objective in this pilot study will be to identify&#xD;
      PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters&#xD;
      change with within breast tumors during chemotherapy treatment over time. Our hope is to use&#xD;
      this information to correlate with pathological response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Anticipated">February 13, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 13, 2024</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>Treatment response correlation between photoacoustic parameters and histopathological measurement.</measure>
    <time_frame>4 to 8 months</time_frame>
    <description>The primary study endpoint will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters (hemoglobin concentration, oxygen saturation, tumor structure) will be made to a pre-treatment point over the course of treatment. Treatment will not be modified on the basis of our observations in this pilot observational study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breast mass characterization</measure>
    <time_frame>30 days</time_frame>
    <description>The secondary study endpoint will investigate if breast masses (benign vs. malignant) can be characterized by PA during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation. No diagnostic information from PA measurements will be used for patient-care/diagnosis as a result of our observations in this pilot observational study</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant Chemotherapy Monitoring</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast Mass Characterization</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort 1 - Neoadjuvant Chemotherapy Monitoring:&#xD;
&#xD;
        Men and women between 20 to 80 years of age with either a biopsy confirmed diagnosis of&#xD;
        breast cancer and receiving neoadjuvant chemotherapy.&#xD;
&#xD;
        Cohort 2 - Breast Mass Characterization:&#xD;
&#xD;
        Men and women between 20 to 80 years of age suspected of having a mammary, benign or&#xD;
        malignant mass and are schedule to undergo diagnostic and clinical work-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cohort 1 - Neoadjuvant Chemotherapy Monitoring:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must give appropriate written informed consent prior to participation in the&#xD;
             study;&#xD;
&#xD;
          -  Subjects must be able and willing to comply with the safety procedures during the&#xD;
             Scanning Period;&#xD;
&#xD;
          -  Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day&#xD;
             the Informed Consent Form is signed;&#xD;
&#xD;
          -  Subjects must be receiving neoadjuvant chemotherapy for locally-advanced breast&#xD;
             cancer.&#xD;
&#xD;
          -  Biopsy-confirmed diagnosis of locally advanced breast cancer; of all molecular&#xD;
             subtypes (ER+/-, PR+/-, HER2+/-).&#xD;
&#xD;
        Cohort 1 - Neoadjuvant Chemotherapy Monitoring:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a past medical history of abnormalities, significant injury, or medical&#xD;
             or surgical procedures (e.g. Silicone/saline implants) involving either breast,&#xD;
             exclusive of the lesion at issue;&#xD;
&#xD;
          -  Subjects with any dermatologic abnormalities (including tattoos, open sores, or&#xD;
             breached skin) involving either breast;&#xD;
&#xD;
          -  Subjects with a current or past medical history of connective tissue disease;&#xD;
&#xD;
          -  Subjects who are pregnant or lactating;&#xD;
&#xD;
          -  Subjects with an implanted electronic device such as a cardiac pacemaker,&#xD;
             defibrillator, or neurological stimulator;&#xD;
&#xD;
          -  Subjects with a history or expectation of significant anxiety associated with&#xD;
             undergoing diagnostic evaluations;&#xD;
&#xD;
          -  Subjects with a history of musculoskeletal disease which may predispose them to&#xD;
             discomfort during the Scanning Period;&#xD;
&#xD;
          -  Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result&#xD;
             of a dermatologic condition); and&#xD;
&#xD;
          -  Subjects, who, in the opinion of the investigator or clinical research coordinator,&#xD;
             may not otherwise be appropriate for inclusion into the study.&#xD;
&#xD;
        Cohort 2 - Breast Mass Characterization:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must give appropriate written informed consent prior to participation in the&#xD;
             study;&#xD;
&#xD;
          -  Subjects must be able and willing to comply with the safety procedures during the&#xD;
             Scanning Period;&#xD;
&#xD;
          -  Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day&#xD;
             the Informed Consent Form is signed;&#xD;
&#xD;
          -  Subjects must be referred to breast diagnostic clinic for investigation of a breast&#xD;
             mass.&#xD;
&#xD;
        Cohort 2 - Breast Mass Characterization:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a past medical history of abnormalities, significant injury, or medical&#xD;
             or surgical procedures (e.g.,silicone/saline implants) involving either breast,&#xD;
             exclusive of the lesion at issue;&#xD;
&#xD;
          -  Subjects with any dermatologic abnormalities (including tattoos, open sores, or&#xD;
             breached skin) involving either breast;&#xD;
&#xD;
          -  Subjects with a current or past medical history of connective tissue disease;&#xD;
&#xD;
          -  Subjects who are pregnant or lactating;&#xD;
&#xD;
          -  Subjects with an implanted electronic device such as a cardiac pacemaker,&#xD;
             defibrillator, or neurological stimulator;&#xD;
&#xD;
          -  Subjects with a history or expectation of significant anxiety associated with&#xD;
             undergoing diagnostic evaluations;&#xD;
&#xD;
          -  Subjects with a history of musculoskeletal disease which may predispose them to&#xD;
             discomfort during the Scanning Period;&#xD;
&#xD;
          -  Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result&#xD;
             of a dermatologic condition); and&#xD;
&#xD;
          -  Subjects, who, in the opinion of the investigator or clinical research coordinator,&#xD;
             may not otherwise be appropriate for inclusion into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory J Czarnota, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregory J Czarnota, PhD, MD</last_name>
    <phone>(416) 480-6128</phone>
    <email>gregory.czarnota@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory J Czarnota, PhD, MD</last_name>
      <phone>(416)480-6128</phone>
      <email>gregory.czarnota@sunnybrook.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 27, 2022</last_update_submitted>
  <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Gregory Czarnota</investigator_full_name>
    <investigator_title>Radiation Oncologist and Clinical Scientist</investigator_title>
  </responsible_party>
  <keyword>chemotherapy</keyword>
  <keyword>photoacoustic imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT04428528
org study id: 456-2016
nct id: NCT04428528
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our objective in this pilot study will be to identify PA parameters that can distinguish
      benign vs. malignant lesions, and also, if PA parameters change with within breast tumors
      during chemotherapy treatment over time.
This study will investigate photoacoustic tissue characteristics of breast lesions both at
      diagnosis, and within a separate subgroup of patients, physiological changes in breast tumors
      during neoadjuvant chemotherapy (NAC). Our objective in this pilot study will be to identify
      PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters
      change with within breast tumors during chemotherapy treatment over time. Our hope is to use
      this information to correlate with pathological response.
observational model: Cohort
time perspective: Prospective
measure: Treatment response correlation between photoacoustic parameters and histopathological measurement.
time frame: 4 to 8 months
description: The primary study endpoint will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters (hemoglobin concentration, oxygen saturation, tumor structure) will be made to a pre-treatment point over the course of treatment. Treatment will not be modified on the basis of our observations in this pilot observational study.
measure: Breast mass characterization
time frame: 30 days
description: The secondary study endpoint will investigate if breast masses (benign vs. malignant) can be characterized by PA during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation. No diagnostic information from PA measurements will be used for patient-care/diagnosis as a result of our observations in this pilot observational study
arm group label: Neoadjuvant Chemotherapy Monitoring
arm group label: Breast Mass Characterization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gregory J Czarnota, PhD, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Gregory J Czarnota, PhD, MD
phone: (416) 480-6128
email: gregory.czarnota@sunnybrook.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Gregory Czarnota
investigator title: Radiation Oncologist and Clinical Scientist
mesh term: Breast Neoplasms