xml: <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/NCT05965180</url>
    </required_header>
    <id_info>
      <org_study_id>UMCC 2022.015</org_study_id>
      <secondary_id>HUM00217834</secondary_id>
      <nct_id>NCT05965180</nct_id>
    </id_info>
    <brief_title>Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe</brief_title>
    <official_title>Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan Rogel 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>University of Michigan Rogel Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy&#xD;
        procedure through a fine needle probe. The needle probe will be in the shape of a biopsy&#xD;
        needle and compatible with the needle insertion mechanism in the transrectal ultrasound&#xD;
        (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the&#xD;
        histological information in its surrounding tissue without any tissue extraction. The needle&#xD;
        probe has been tested in prostate tissue samples and whole human prostates ex vivo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Demonstration of reliable measurements</measure>
      <time_frame>day 1</time_frame>
      <description>The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one.&#xD;
  We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determining the ability to observe differences between benign and cancerous regions</measure>
      <time_frame>day 1</time_frame>
      <description>The secondary aim of this study is documenting our ability to observe differences between the PASA linear slope values derived from benign and cancerous regions, i.e., to detect the difference of 0.05 of 0.19, 0.17, 0.14, 0.20 dB/MHz between the means of the linear slopes in benign and cancerous regions at the wavelengths of 1220 nm, 1370 nm, 800 nm and 266 nm, respectively.&#xD;
  We will aim at differentiating the measurements in benign and cancerous regions at specific wavelengths. We have a null hypothesis for each wavelength that at this specific wavelength, our measurement cannot differentiate the benign and cancerous regions. We will test the hypothesis with paired t-tests.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Biopsy</arm_group_label>
      <description>Patients will be identified once prostate biopsies have been scheduled. Once enrolled on trial, patients will undergo standard biopsy procedure as per clinical care. During this biopsy, research measurements will be completed using the fine needle photoacoustic probe.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fine Needle Photoacoustic Probe</intervention_name>
      <description>Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction</description>
      <arm_group_label>Biopsy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with planned prostate biopsy procedures will be recruited through U-M Urology&#xD;
          Clinics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) Planned prostate biopsy as part of routine clinical care&#xD;
  &#xD;
            -  2) &gt; 40 and &lt;80 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) Known history of bleeding disorders or&#xD;
  &#xD;
            -  2) Patients taking anticoagulants, no matter doses or washout time&#xD;
  &#xD;
            -  3) Known allergy to silicone material&#xD;
  &#xD;
            -  4) Unable to provide informed consent&#xD;
  &#xD;
            -  5) Either the surgeon or the patient do not think the patient will not be able to&#xD;
               complete all parts of the study, the patient will be excluded&#xD;
  &#xD;
            -  6) Involved in other investigational studies.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guan Xu, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cancer AnswerLine</last_name>
      <phone>1-800-865-1125</phone>
      <email>CancerAnswerLine@med.umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan Rogel Cancer Center</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Cancer AnswerLine</last_name>
        <phone>800-865-1125</phone>
        <email>CancerAnswerLine@med.umich.edu</email>
      </contact>
      <investigator>
        <last_name>Guan Xu, Phd</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Biopsy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic 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>
  
  
text: 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/NCT05965180
  org study id: UMCC 2022.015
  secondary id: HUM00217834
  nct id: NCT05965180
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy
        procedure through a fine needle probe. The needle probe will be in the shape of a biopsy
        needle and compatible with the needle insertion mechanism in the transrectal ultrasound
        (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the
        histological information in its surrounding tissue without any tissue extraction. The needle
        probe has been tested in prostate tissue samples and whole human prostates ex vivo.
  observational model: Other
  time perspective: Prospective
  measure: Demonstration of reliable measurements
  time frame: day 1
  description: The primary aim of this study is to demonstrate that our fine needle PA probe can acquire reliable measurements of prostate glands. This will be indicated by a signal-to-noise ratio of the measurements that is larger than one.
  We will calculate the signal to noise ratio of the signals as the peak-to-peak signal magnitude over the amplitude of the system background signal. The technical failure is that we will not be able to achieve measurements with signal-to-noise ratios larger than 1 in 10% of the measurements. We will have a futility analysis after first 5 patients are completed (thus 10 measurements). If of those 10 measurements, 2 have a SNR less 1, then the study will be stopped as it is unlikely to meet its 90% target.
  measure: Determining the ability to observe differences between benign and cancerous regions
  time frame: day 1
  description: The secondary aim of this study is documenting our ability to observe differences between the PASA linear slope values derived from benign and cancerous regions, i.e., to detect the difference of 0.05 of 0.19, 0.17, 0.14, 0.20 dB/MHz between the means of the linear slopes in benign and cancerous regions at the wavelengths of 1220 nm, 1370 nm, 800 nm and 266 nm, respectively.
  We will aim at differentiating the measurements in benign and cancerous regions at specific wavelengths. We have a null hypothesis for each wavelength that at this specific wavelength, our measurement cannot differentiate the benign and cancerous regions. We will test the hypothesis with paired t-tests.
  arm group label: Biopsy
  description: Patients will be identified once prostate biopsies have been scheduled. Once enrolled on trial, patients will undergo standard biopsy procedure as per clinical care. During this biopsy, research measurements will be completed using the fine needle photoacoustic probe.
  intervention type: Device
  intervention name: Fine Needle Photoacoustic Probe
  description: Fine Needle Photoacoustic Probe guided by the standard biopsy system without tissue core extraction
  arm group label: Biopsy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guan Xu, Phd
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Cancer AnswerLine
  phone: 1-800-865-1125
  email: CancerAnswerLine@med.umich.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No