<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/NCT01688414</url>
  </required_header>
  <id_info>
    <org_study_id>VAR0083</org_study_id>
    <secondary_id>NCI-2012-01654</secondary_id>
    <nct_id>NCT01688414</nct_id>
  </id_info>
  <brief_title>Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer</brief_title>
  <official_title>Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies imaging during surgery in diagnosing patients with&#xD;
      prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,&#xD;
      bladder, or kidney cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. The primary objective of this pilot study is to assess the ability of fluorescent imaging&#xD;
      and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant&#xD;
      tissue.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To qualitatively determine the possible benefit of PAI and fluorescent imaging over&#xD;
      traditional white light imaging.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left Stanford&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer])</measure>
    <time_frame>Up to 6 months after surgery</time_frame>
    <description>The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fluorescence intensity (signal-to-noise ratio in the region of interest)</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)</measure>
    <time_frame>During the time of surgery</time_frame>
    <description>Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Kidney Tumor</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Diagnostic (fluorescence imaging, PAI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>photoacoustic imaging</intervention_name>
    <description>Undergo PAI</description>
    <arm_group_label>Diagnostic (fluorescence imaging, PAI)</arm_group_label>
    <other_name>optoacoustic imaging</other_name>
    <other_name>PAI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fluorescence imaging</intervention_name>
    <description>Undergo fluorescence imaging</description>
    <arm_group_label>Diagnostic (fluorescence imaging, PAI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robot-assisted laparoscopic surgery</intervention_name>
    <description>Undergo robot-assisted laparoscopic surgery</description>
    <arm_group_label>Diagnostic (fluorescence imaging, PAI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or&#xD;
             kidney cancer based on previous biopsies or procedures OR a strong concern for a&#xD;
             kidney malignancy based on computed tomography (CT) or magnetic resonance imaging&#xD;
             (MRI) imaging&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a surgical history or anatomic variant that would preclude robot&#xD;
             assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia&#xD;
             repair with mesh)&#xD;
&#xD;
          -  Patients with medical co-morbidities who cannot tolerate laparoscopic surgery&#xD;
             secondary to intra-abdominal carbon dioxide insufflation&#xD;
&#xD;
          -  Patients with documented allergy or adverse drug reaction to indocyanine green or&#xD;
             baseline serum creatinine greater than 1.5 mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Gonzalgo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</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>Kidney 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/NCT01688414
org study id: VAR0083
secondary id: NCI-2012-01654
nct id: NCT01688414
lead sponsor: 
collaborator: 
This pilot clinical trial studies imaging during surgery in diagnosing patients with
      prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,
      bladder, or kidney cancer
PRIMARY OBJECTIVES:

      I. The primary objective of this pilot study is to assess the ability of fluorescent imaging
      and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant
      tissue.

      SECONDARY OBJECTIVES:

      I. To qualitatively determine the possible benefit of PAI and fluorescent imaging over
      traditional white light imaging.

      OUTLINE:

      Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer])
time frame: Up to 6 months after surgery
description: The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.
measure: Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
time frame: During the time of surgery
description: The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
measure: Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
time frame: During the time of surgery
description: The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
measure: Fluorescence intensity (signal-to-noise ratio in the region of interest)
time frame: During the time of surgery
description: The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
measure: Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
time frame: During the time of surgery
description: The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
measure: Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
time frame: During the time of surgery
description: Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
measure: Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
time frame: During the time of surgery
description: Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
measure: Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
time frame: During the time of surgery
description: Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
arm group label: Diagnostic (fluorescence imaging, PAI)
arm group type: Experimental
description: Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
intervention type: Procedure
intervention name: photoacoustic imaging
description: Undergo PAI
arm group label: Diagnostic (fluorescence imaging, PAI)
other name: optoacoustic imaging
other name: PAI
intervention type: Procedure
intervention name: fluorescence imaging
description: Undergo fluorescence imaging
arm group label: Diagnostic (fluorescence imaging, PAI)
intervention type: Procedure
intervention name: robot-assisted laparoscopic surgery
description: Undergo robot-assisted laparoscopic surgery
arm group label: Diagnostic (fluorescence imaging, PAI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mark Gonzalgo
role: Principal Investigator
affiliation: Stanford University
country: United States
responsible party type: Sponsor
mesh term: Kidney Neoplasms