<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/NCT01730365</url>
  </required_header>
  <id_info>
    <org_study_id>NL40578.031.12</org_study_id>
    <nct_id>NCT01730365</nct_id>
  </id_info>
  <brief_title>Optical Detection of Malignancy During Percutaneous Interventions</brief_title>
  <official_title>Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of application possibilities of optical spectroscopy within the field of&#xD;
      oncology. Optical spectroscopy enables the possibility to specifically differentiate between&#xD;
      different (human) tissues. The hypothesis is that incorporation of this technique into&#xD;
      existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of&#xD;
      these devices. The purpose is to improve and speed up the diagnostics and therapy of the&#xD;
      malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      In this observational study the investigators aim to evaluate whether optical spectroscopy&#xD;
      can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous&#xD;
      interventions in lung, liver, and breast.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      During the measurement procedure, possible improvements of the measurement hardware will be&#xD;
      recorded. Analysis of this documentation will provide information for possible alterations of&#xD;
      hardware design for improved clinical applicability in the future. Special attention will be&#xD;
      paid to observe how the procedure fits in the standard workflow of the radiologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differentiation between normal and malignant tissue</measure>
    <time_frame>Day 0</time_frame>
    <description>Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>Pulmonary Coin Lesion</condition>
  <condition>Colon Cancer Liver Metastasis</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Histological biopsy procedures</arm_group_label>
    <description>Patients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Core biopsy procedure</intervention_name>
    <description>Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.</description>
    <arm_group_label>Histological biopsy procedures</arm_group_label>
    <other_name>Histological biopsy procedure</other_name>
    <other_name>Standard biopsy procedure</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsies are taken from the enrolled patients and these biopsies are send to the pathology&#xD;
      department for histopathological analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients are all patients, who are scheduled for a standard core biopsy of lung,&#xD;
        liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute&#xD;
        (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the &quot;patient informatie&quot;&#xD;
        will be used and the informed consent must be signed prior to the intervention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a suspicious lesion in lung or liver who are scheduled for a standard&#xD;
             core biopsy procedure&#xD;
&#xD;
          -  Patient planned for percutaneous RFA of colorectal liver metastasis&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
          -  Breast patients with a BIRADS score 4 or 5&#xD;
&#xD;
        General Exclusion criteria:&#xD;
&#xD;
          -  Patients who have higher risk of bleeding&#xD;
&#xD;
          -  Patients with suspected sensitivity to light; e.g. patients who have had photodynamic&#xD;
             therapy&#xD;
&#xD;
        Breast Specific Exclusion criteria:&#xD;
&#xD;
          -  Patients who have a history of breast cancer and/or who have received prior&#xD;
             chemotherapy, endocrine therapy, or radiation therapy&#xD;
&#xD;
          -  Patients who have breast implants&#xD;
&#xD;
          -  Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque&#xD;
             lesions)&#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>Theo Ruers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 8, 2016</last_update_submitted>
  <last_update_submitted_qc>April 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spectroscopy</keyword>
  <keyword>tumour</keyword>
  <keyword>biopsy</keyword>
  <keyword>malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Solitary Pulmonary Nodule</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/NCT01730365
org study id: NL40578.031.12
nct id: NCT01730365
lead sponsor: 
has dmc: Yes
Investigation of application possibilities of optical spectroscopy within the field of
      oncology. Optical spectroscopy enables the possibility to specifically differentiate between
      different (human) tissues. The hypothesis is that incorporation of this technique into
      existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of
      these devices. The purpose is to improve and speed up the diagnostics and therapy of the
      malignancies.
Primary Objective:

      In this observational study the investigators aim to evaluate whether optical spectroscopy
      can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous
      interventions in lung, liver, and breast.

      Secondary Objective:

      During the measurement procedure, possible improvements of the measurement hardware will be
      recorded. Analysis of this documentation will provide information for possible alterations of
      hardware design for improved clinical applicability in the future. Special attention will be
      paid to observe how the procedure fits in the standard workflow of the radiologist.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Differentiation between normal and malignant tissue
time frame: Day 0
description: Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations
arm group label: Histological biopsy procedures
description: Patients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis
intervention type: Procedure
intervention name: Core biopsy procedure
description: Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.
arm group label: Histological biopsy procedures
other name: Histological biopsy procedure
other name: Standard biopsy procedure
Biopsies are taken from the enrolled patients and these biopsies are send to the pathology
      department for histopathological analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theo Ruers, MD
role: Principal Investigator
affiliation: Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Solitary Pulmonary Nodule