<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/NCT02206048</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0885</org_study_id>
    <secondary_id>14037870</secondary_id>
    <secondary_id>NCI-2014-01790</secondary_id>
    <nct_id>NCT02206048</nct_id>
  </id_info>
  <brief_title>Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix</brief_title>
  <official_title>Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if it is possible to get high-resolution&#xD;
      microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right&#xD;
      before a biopsy of the cervix. Researchers also want to learn if HRME images can show the&#xD;
      difference between cancerous tissue and normal cervical tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, after you are in the operating room and under&#xD;
      general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the&#xD;
      cervix. Images will be collected with the probe from the HRME device. The HRME probe is a&#xD;
      long thin tube with a camera at the tip. This probe will be applied to the cervix and images&#xD;
      obtained. These images will be used for research. This should add about 10 minutes to the&#xD;
      total time you are in the operating room.&#xD;
&#xD;
      There will be no change to the planned standard-of-care colposcopy and biopsy.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      A member of the research team will call you within 30 days after the procedure to ask how you&#xD;
      are feeling and if you are having any symptoms. This call should last about 5 minutes.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Your active participation in this study will be over after the biopsy.&#xD;
&#xD;
      This is an investigational study. The goal of this clinical research study is to learn if it&#xD;
      is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue&#xD;
      from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to&#xD;
      learn if HRME images can show the difference between cancerous tissue and normal cervical&#xD;
      tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2015</start_date>
  <completion_date type="Actual">April 21, 2021</completion_date>
  <primary_completion_date type="Actual">April 21, 2021</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>Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization</measure>
    <time_frame>1 day</time_frame>
    <description>Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging</measure>
    <time_frame>1 day</time_frame>
    <description>AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Cervix Carcinoma</condition>
  <arm_group>
    <arm_group_label>High-Resolution Microendoscopy (HRME)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proflavine</intervention_name>
    <description>0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.</description>
    <arm_group_label>High-Resolution Microendoscopy (HRME)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High-Resolution Microendoscopy (HRME) Imaging</intervention_name>
    <description>in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
    <arm_group_label>High-Resolution Microendoscopy (HRME)</arm_group_label>
    <other_name>HRME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any woman with a confirmed preoperative diagnosis of cervical AIS, including&#xD;
             co-existing squamous CIN and/or microinvasive cancer&#xD;
&#xD;
          2. Women undergoing cold knife cone (CKC) of the cervix at MD Anderson&#xD;
&#xD;
          3. Negative pregnancy test for women of child-bearing potential&#xD;
&#xD;
          4. Women who are &gt;/= 21 years of age and &lt; 65 years of age&#xD;
&#xD;
          5. Ability to understand and the willingness to provide informed consent and sign a&#xD;
             written Informed Consent Document (ICD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women &lt; 21 years of age and &gt;/= 65 years of age&#xD;
&#xD;
          2. Women with a known allergy to proflavine or acriflavine&#xD;
&#xD;
          3. Women who are pregnant or nursing&#xD;
&#xD;
          4. Patients unable or unwilling to provide informed consent or sign a written Informed&#xD;
             Consent Document (ICD)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Schmeler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>April 18, 2022</results_first_submitted>
  <results_first_submitted_qc>July 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2022</results_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervix Carcinoma</keyword>
  <keyword>Cervical adenocarcinoma in situ</keyword>
  <keyword>AIS</keyword>
  <keyword>Cervical intraepithelial neoplasia</keyword>
  <keyword>CIN</keyword>
  <keyword>microinvasive carcinoma of the cervix</keyword>
  <keyword>cold knife cone of the cervix</keyword>
  <keyword>CKC</keyword>
  <keyword>High-Resolution Microendoscopy</keyword>
  <keyword>HRME</keyword>
  <keyword>Proflavine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proflavine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT02206048/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>High-Resolution Microendoscopy (HRME)</title>
          <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.&#xD;
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.&#xD;
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Change in OR schedule and availability of study staff</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>High-Resolution Microendoscopy (HRME)</title>
          <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.&#xD;
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.&#xD;
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization</title>
        <description>Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.</description>
        <time_frame>1 day</time_frame>
        <population>Due to not meeting enrollment requirements, data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>High-Resolution Microendoscopy (HRME)</title>
            <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.&#xD;
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.&#xD;
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization</title>
          <description>Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.</description>
          <population>Due to not meeting enrollment requirements, data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging</title>
        <description>AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.</description>
        <time_frame>1 day</time_frame>
        <population>Due to low accrual, no specimens were collected to be analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>High-Resolution Microendoscopy (HRME)</title>
            <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.&#xD;
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.&#xD;
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
          </group>
        </group_list>
        <measure>
          <title>Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging</title>
          <description>AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.</description>
          <population>Due to low accrual, no specimens were collected to be analyzed</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events will be captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdraws consent. Serious adverse events must be followed until clinical recovery is complete and laboratory tests have returned to baseline, progression of the event has stabilized, or there has been acceptable resolution of the event.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>High-Resolution Microendoscopy (HRME)</title>
          <description>Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.&#xD;
Proflavine: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.&#xD;
High-Resolution Microendoscopy (HRME) Imaging: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to low accrual no analysis conducted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kathleen M. Schmeler, MD</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>713-745-3518</phone>
      <email>kschmele@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02206048
org study id: 2013-0885
secondary id: 14037870
secondary id: NCI-2014-01790
nct id: NCT02206048
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn if it is possible to get high-resolution
      microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right
      before a biopsy of the cervix. Researchers also want to learn if HRME images can show the
      difference between cancerous tissue and normal cervical tissue.
If you agree to take part in this study, after you are in the operating room and under
      general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the
      cervix. Images will be collected with the probe from the HRME device. The HRME probe is a
      long thin tube with a camera at the tip. This probe will be applied to the cervix and images
      obtained. These images will be used for research. This should add about 10 minutes to the
      total time you are in the operating room.

      There will be no change to the planned standard-of-care colposcopy and biopsy.

      Follow-Up:

      A member of the research team will call you within 30 days after the procedure to ask how you
      are feeling and if you are having any symptoms. This call should last about 5 minutes.

      Length of Study:

      Your active participation in this study will be over after the biopsy.

      This is an investigational study. The goal of this clinical research study is to learn if it
      is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue
      from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to
      learn if HRME images can show the difference between cancerous tissue and normal cervical
      tissue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization
time frame: 1 day
description: Methodology determined feasible if in-vivo HRME images are acquired in if 18 of the 20 participants enrolled in the study.
measure: Adenocarcinoma In-Situ (AIS) Distinguished From Normal Cervical Tissue Using High-Resolution Microendoscopy (HRME) Imaging
time frame: 1 day
description: AIS finding tabulated by the CKC specimen results as determined by pathology. Concordance of HRME images taken ex-vivo estimated with pathology findings with a 90% credible, assuming a beta (1.8, 0.2) prior distribution for the concordance.
arm group label: High-Resolution Microendoscopy (HRME)
arm group type: Experimental
description: Before participant's cold knife cone biopsy (CKC), topical application of 0.01% proflavine solution applied to cervix. HRME probe applied to cervix and high-resolution images obtained. Participant undergoes cervical biopsies of any abnormal areas noted with colposcopy and/or HRME. Immediately following the CKC, the removed surgical specimen evaluated. Proflavine reapplied to surgical specimen and repeat evaluation with HRME performed and high-resolution images obtained.
intervention type: Drug
intervention name: Proflavine
description: 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.
arm group label: High-Resolution Microendoscopy (HRME)
intervention type: Procedure
intervention name: High-Resolution Microendoscopy (HRME) Imaging
description: in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
arm group label: High-Resolution Microendoscopy (HRME)
other name: HRME
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: No
last name: Kathleen Schmeler, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma in Situ
mesh term: Proflavine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to low accrual no analysis conducted.
point of contact: 