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/NCT06004908</url>
    </required_header>
    <id_info>
      <org_study_id>MR imaging in uterus</org_study_id>
      <nct_id>NCT06004908</nct_id>
    </id_info>
    <brief_title>Role of MRI in Diagnosis of Postmenopausal Bleeding Causes</brief_title>
    <official_title>Role of MRI in Diagnosis of Causes of Postmenopausal Bleeding in Correlation to Histopathological Results</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to determine the diagnostic performance of MRI of endometrial&#xD;
        pathology in postmenopausal women with postmenopausal bleeding&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postmenopausal bleeding is a common clinical problem accounting for approximately 5% of&#xD;
        office visits to a general gynecologist.&#xD;
  &#xD;
        Postmenopausal bleeding has been defined as:&#xD;
  &#xD;
          1. Vaginal bleeding occurring at least 6 months after complete cessation of menses in women&#xD;
             not on hormonal replacement therapy (HRT).&#xD;
  &#xD;
          2. Noncyclic vaginal bleeding occurring in postmenopausal women who are receiving HRT&#xD;
             Abnormal vaginal bleeding may be caused by a number of gynecologic or nongynecologic&#xD;
             disorders. When evaluating a gynecologic etiology, the primary goal is to eliminate the&#xD;
             possibility of endometrial cancer which is the cause of bleeding in approximately 10% of&#xD;
             postmenopausal women presenting with this complaint and is the presenting symptom in 90%&#xD;
             of women with endometrial cancer.&#xD;
  &#xD;
        Other common gynecologic etiologies include endometrial polyps, endometrial hyperplasia, and&#xD;
        submucosal fibroids along with the use of hormone replacement therapy, tamoxifen, and&#xD;
        phytoestrogens Those pathologies should be discriminated to navigate the treatment process.&#xD;
        Transvaginal ultrasonography (TVS) is the most efficient first-step technique for diagnosis&#xD;
        of postmenopausal bleeding . The sensitivity of TVS to detect endometrial pathologies is&#xD;
        high, but its specificity is low . Therefore, biopsy is recommended as a second-step&#xD;
        diagnostic method when endometrial thickness exceeds 4 mm . However, endometrial biopsy or&#xD;
        dilatation and curettage (D&amp;C) may not be possible in postmenopausal patients due to&#xD;
        endometrial atrophy, endometrial adhesions, or the requirement of general anesthesia. .&#xD;
        Furthermore, besides pain and discomfort with endometrial sampling procedures, in some&#xD;
        occasions such as vaginal/cervical stenosis or pelvic organ prolapse these procedures may be&#xD;
        difficult to be done . Additionally, blind sampling may not be an effective approach for&#xD;
        diagnosis of focal endometrial lesions and may be subject to sampling error .&#xD;
  &#xD;
        MRI is an emerging modality for various reasons, such as exquisite soft-tissue resolution,&#xD;
        its capability of multiplanar imaging, characterization, high sensitivity, and lack of&#xD;
        ionizing radiation.&#xD;
  &#xD;
        The sensitivity of MRI in identifying acute uterine pathologies is 96.6 % With recent&#xD;
        advances in MR imaging techniques, diffusion weighted (DW) imaging and ADC value are useful&#xD;
        in characterization of endometrial lesions because malignant lesions show high cellularity&#xD;
        with little extracellular space which give restricted motion of water molecules and lower ADC&#xD;
        values in contrast to benign lesions and normal tissues .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding</measure>
      <time_frame>baseline</time_frame>
      <description>anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding</description>
    </primary_outcome>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Postmenopausal Bleeding</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MRI</intervention_name>
      <description>a type of scan that uses strong magnetic field sand radio waves to produce detailed images of the inside of the body</description>
      <other_name>Magnetic resonance imaging</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any female patient after menopause suffering from vaginal bleeding&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Any female patient after menopause suffering from vaginal bleeding.&#xD;
  &#xD;
            2. Patients receiving tamoxifen with vaginal bleeding.&#xD;
  &#xD;
            3. Patient had histopathological biopsy examination either by total hysterectomy,&#xD;
               hysteroscopy or D &amp;C.&#xD;
  &#xD;
            4. Patient must have local cause&#xD;
  &#xD;
               -&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
          1. Patients not amenable for MRI examination 2. Patients not in menopause 3. Patients have&#xD;
          general bleeding tendency 4. Patients not underwent histopathological biopsy examination&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hossam ElDen Mustafa Kamel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>unaffilitated</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>kholoud khaled salem, graduated</last_name>
      <phone>01050111754</phone>
      <email>Kkholod676@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mostafa Hashem Mahmoud othma, MD</last_name>
      <phone>01005618665</phone>
      <email>hashemradiol@yahoo.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Dubinsky TJ, Parvey HR, Maklad N. The role of transvaginal sonography and endometrial biopsy in the evaluation of peri- and postmenopausal bleeding. AJR Am J Roentgenol. 1997 Jul;169(1):145-9. doi: 10.2214/ajr.169.1.9207515.</citation>
      <PMID>9207515</PMID>
    </reference>
    <reference>
      <citation>Karlsson B, Granberg S, Wikland M, Ylostalo P, Torvid K, Marsal K, Valentin L. Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding--a Nordic multicenter study. Am J Obstet Gynecol. 1995 May;172(5):1488-94. doi: 10.1016/0002-9378(95)90483-2.</citation>
      <PMID>7755059</PMID>
    </reference>
    <reference>
      <citation>Gull B, Karlsson B, Milsom I, Granberg S. Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal bleeding and transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol. 2003 Feb;188(2):401-8. doi: 10.1067/mob.2003.154.</citation>
      <PMID>12592247</PMID>
    </reference>
    <reference>
      <citation>Foti PV, Tonolini M, Costanzo V, Mammino L, Palmucci S, Cianci A, Ettorre GC, Basile A. Cross-sectional imaging of acute gynaecologic disorders: CT and MRI findings with differential diagnosis-part II: uterine emergencies and pelvic inflammatory disease. Insights Imaging. 2019 Dec 20;10(1):118. doi: 10.1186/s13244-019-0807-6.</citation>
      <PMID>31858287</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Kholoud Khaled Salem Ali</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004908
  org study id: MR imaging in uterus
  nct id: NCT06004908
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to determine the diagnostic performance of MRI of endometrial
        pathology in postmenopausal women with postmenopausal bleeding
  Postmenopausal bleeding is a common clinical problem accounting for approximately 5% of
        office visits to a general gynecologist.
  
        Postmenopausal bleeding has been defined as:
  
          1. Vaginal bleeding occurring at least 6 months after complete cessation of menses in women
             not on hormonal replacement therapy (HRT).
  
          2. Noncyclic vaginal bleeding occurring in postmenopausal women who are receiving HRT
             Abnormal vaginal bleeding may be caused by a number of gynecologic or nongynecologic
             disorders. When evaluating a gynecologic etiology, the primary goal is to eliminate the
             possibility of endometrial cancer which is the cause of bleeding in approximately 10% of
             postmenopausal women presenting with this complaint and is the presenting symptom in 90%
             of women with endometrial cancer.
  
        Other common gynecologic etiologies include endometrial polyps, endometrial hyperplasia, and
        submucosal fibroids along with the use of hormone replacement therapy, tamoxifen, and
        phytoestrogens Those pathologies should be discriminated to navigate the treatment process.
        Transvaginal ultrasonography (TVS) is the most efficient first-step technique for diagnosis
        of postmenopausal bleeding . The sensitivity of TVS to detect endometrial pathologies is
        high, but its specificity is low . Therefore, biopsy is recommended as a second-step
        diagnostic method when endometrial thickness exceeds 4 mm . However, endometrial biopsy or
        dilatation and curettage (D&C) may not be possible in postmenopausal patients due to
        endometrial atrophy, endometrial adhesions, or the requirement of general anesthesia. .
        Furthermore, besides pain and discomfort with endometrial sampling procedures, in some
        occasions such as vaginal/cervical stenosis or pelvic organ prolapse these procedures may be
        difficult to be done . Additionally, blind sampling may not be an effective approach for
        diagnosis of focal endometrial lesions and may be subject to sampling error .
  
        MRI is an emerging modality for various reasons, such as exquisite soft-tissue resolution,
        its capability of multiplanar imaging, characterization, high sensitivity, and lack of
        ionizing radiation.
  
        The sensitivity of MRI in identifying acute uterine pathologies is 96.6 % With recent
        advances in MR imaging techniques, diffusion weighted (DW) imaging and ADC value are useful
        in characterization of endometrial lesions because malignant lesions show high cellularity
        with little extracellular space which give restricted motion of water molecules and lower ADC
        values in contrast to benign lesions and normal tissues .
  observational model: Case-Crossover
  time perspective: Prospective
  measure: comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding
  time frame: baseline
  description: anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding
  intervention type: Device
  intervention name: MRI
  description: a type of scan that uses strong magnetic field sand radio waves to produce detailed images of the inside of the body
  other name: Magnetic resonance imaging
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Hossam ElDen Mustafa Kamel, MD
  role: Principal Investigator
  affiliation: unaffilitated
  last name: kholoud khaled salem, graduated
  phone: 01050111754
  email: Kkholod676@gmail.com
  last name: Mostafa Hashem Mahmoud othma, MD
  phone: 01005618665
  email: hashemradiol@yahoo.com
  citation: Dubinsky TJ, Parvey HR, Maklad N. The role of transvaginal sonography and endometrial biopsy in the evaluation of peri- and postmenopausal bleeding. AJR Am J Roentgenol. 1997 Jul;169(1):145-9. doi: 10.2214/ajr.169.1.9207515.
  PMID: 9207515
  citation: Karlsson B, Granberg S, Wikland M, Ylostalo P, Torvid K, Marsal K, Valentin L. Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding--a Nordic multicenter study. Am J Obstet Gynecol. 1995 May;172(5):1488-94. doi: 10.1016/0002-9378(95)90483-2.
  PMID: 7755059
  citation: Gull B, Karlsson B, Milsom I, Granberg S. Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal bleeding and transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol. 2003 Feb;188(2):401-8. doi: 10.1067/mob.2003.154.
  PMID: 12592247
  citation: Foti PV, Tonolini M, Costanzo V, Mammino L, Palmucci S, Cianci A, Ettorre GC, Basile A. Cross-sectional imaging of acute gynaecologic disorders: CT and MRI findings with differential diagnosis-part II: uterine emergencies and pelvic inflammatory disease. Insights Imaging. 2019 Dec 20;10(1):118. doi: 10.1186/s13244-019-0807-6.
  PMID: 31858287
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Kholoud Khaled Salem Ali
  investigator title: Assistant lecturer
  mesh term: Uterine Hemorrhage
  mesh term: Hemorrhage