<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/NCT01710085</url>
  </required_header>
  <id_info>
    <org_study_id>KUAP(T)-2012/39</org_study_id>
    <nct_id>NCT01710085</nct_id>
  </id_info>
  <brief_title>Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients</brief_title>
  <official_title>Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uludag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uludag University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometrial and cervical cancers are one of the most common malignancies seen in females.&#xD;
      Identification of recurrent disease in early phases of treatment carries a primary importance&#xD;
      on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new&#xD;
      technique recently started to be performed in body imaging and has potential ability to&#xD;
      detect recurrent disease. The aim of this study is to investigate the diagnostic impact of&#xD;
      DWI in detection of recurrent disease in patients treated with curative surgery in&#xD;
      endometrial and cervical cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometrial and cervical cancers are one of the most common malignancies seen in female&#xD;
      genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or&#xD;
      neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment&#xD;
      options depending on the stage.&#xD;
&#xD;
      Identification of recurrent disease in early phases carries a primary importance on the&#xD;
      prognosis.&#xD;
&#xD;
      Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body&#xD;
      imaging has potential ability to distinguish recurrent disease from normal tissue or&#xD;
      fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection&#xD;
      of recurrence rate in patients treated with curative surgery in endometrial and cervical&#xD;
      cancer.&#xD;
&#xD;
      All patients who had curative surgery due to endometrial or cervical cancer will be included&#xD;
      to the study. Patients will be examined with DWI in addition to routine sequences including&#xD;
      contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive&#xD;
      and negative predictive values of the study will be investigated from the data derived from&#xD;
      DWI studies and will be correlated with data obtained by conventional radiologic, nuclear&#xD;
      imaging studies including PET-CT, as well as pathologic verifications during follow-up&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.</measure>
    <time_frame>18 months</time_frame>
    <description>Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Diffusion weighted imaging, Recurrence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011</intervention_name>
    <description>Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields.</description>
    <arm_group_label>Diffusion weighted imaging, Recurrence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologic diagnosis of cervical or endometrial cancer.&#xD;
&#xD;
          -  Patients treated with curative surgery (hysterectomy)will be involved on a voluntary&#xD;
             basis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear&#xD;
             implants, claustrophobic patients)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gürsel Savcı, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Uludag University Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kadir Hacıkurt, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uludag University Faculty of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kadir Hacıkurt</last_name>
    <phone>+905055873273</phone>
    <email>hacikurt@uludag.edu.tr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gürsel Savcı</last_name>
    <email>gsavci@uludag.edu.tr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uludağ Üniversitesi</name>
      <address>
        <city>Bursa</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kadir Hacıkurt</last_name>
      <phone>+905055873273</phone>
      <email>hacikurt@uludag.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Kadir Hacıkurt</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gürsel Savcı</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uludag University</investigator_affiliation>
    <investigator_full_name>Kadir Hacikurt</investigator_full_name>
    <investigator_title>Dr. Kadir Hacıkurt</investigator_title>
  </responsible_party>
  <keyword>Diffusion weighted MRI</keyword>
  <keyword>Curative surgery</keyword>
  <keyword>Recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Body Weight</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/NCT01710085
org study id: KUAP(T)-2012/39
nct id: NCT01710085
lead sponsor: 
has dmc: No
Endometrial and cervical cancers are one of the most common malignancies seen in females.
      Identification of recurrent disease in early phases of treatment carries a primary importance
      on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new
      technique recently started to be performed in body imaging and has potential ability to
      detect recurrent disease. The aim of this study is to investigate the diagnostic impact of
      DWI in detection of recurrent disease in patients treated with curative surgery in
      endometrial and cervical cancer.
Endometrial and cervical cancers are one of the most common malignancies seen in female
      genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or
      neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment
      options depending on the stage.

      Identification of recurrent disease in early phases carries a primary importance on the
      prognosis.

      Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body
      imaging has potential ability to distinguish recurrent disease from normal tissue or
      fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection
      of recurrence rate in patients treated with curative surgery in endometrial and cervical
      cancer.

      All patients who had curative surgery due to endometrial or cervical cancer will be included
      to the study. Patients will be examined with DWI in addition to routine sequences including
      contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive
      and negative predictive values of the study will be investigated from the data derived from
      DWI studies and will be correlated with data obtained by conventional radiologic, nuclear
      imaging studies including PET-CT, as well as pathologic verifications during follow-up
      period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
measure: Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
time frame: 18 months
description: Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
arm group label: Diffusion weighted imaging, Recurrence
arm group type: Experimental
intervention type: Device
intervention name: Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011
description: Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields.
arm group label: Diffusion weighted imaging, Recurrence
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gürsel Savcı, Prof.
role: Study Director
affiliation: Uludag University Faculty of Medicine
last name: Kadir Hacıkurt, Dr.
role: Principal Investigator
affiliation: Uludag University Faculty of Medicine
last name: Kadir Hacıkurt
phone: +905055873273
email: hacikurt@uludag.edu.tr
last name: Gürsel Savcı
email: gsavci@uludag.edu.tr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Uludag University
investigator full name: Kadir Hacikurt
investigator title: Dr. Kadir Hacıkurt
mesh term: Endometrial Neoplasms
mesh term: Body Weight