<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/NCT03290807</url>
  </required_header>
  <id_info>
    <org_study_id>SPECT/CT in osteoarthritis</org_study_id>
    <nct_id>NCT03290807</nct_id>
  </id_info>
  <brief_title>The Role of Tc 99m MDP SPECT/CT in Osteoarthritis</brief_title>
  <official_title>The Role of Tc 99m MDP SPECT/CT in Osteoarthritis</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>
      Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether&#xD;
      it is related to clinical findings and it could reflect clinical disease activity, and to&#xD;
      determine the usefulness of SPECT/CT in early detection of OA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses&#xD;
      over years. After the classification and reporting of OA were established by American College&#xD;
      of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported&#xD;
      by plain radiographic findings.&#xD;
&#xD;
      Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend&#xD;
      to depend on the clinical symptoms, rather than the objective imaging findings.&#xD;
&#xD;
      MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as&#xD;
      bone marrow oedema, but it has some limitation in that it may have false positive or false&#xD;
      negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is&#xD;
      relatively sensitive because it reflects the early physiological changes of joints. But its&#xD;
      image is planar that it cannot give enough information for the anatomic localization, and the&#xD;
      image is overlapped.&#xD;
&#xD;
      To compensate for the defects of these imaging methods, bone single photon emission computed&#xD;
      tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.&#xD;
&#xD;
      Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone&#xD;
      SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.&#xD;
&#xD;
      The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional&#xD;
      imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and&#xD;
      follow-up after procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings.</measure>
    <time_frame>Baseline</time_frame>
    <description>Osteoarthritic patients will be examined with 99mTc-methylene diphosphonate (MDP) bone SPECT, the sites of uptake will be localized.&#xD;
Simple radiograph and physical examination will be assessed.The relationships between clinical findings, simple radiographic findings and the intensity of uptake in SPECT will be analyzed.</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Osteoarthritis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPECT/CT</intervention_name>
    <description>Combined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Adult patient above 30 years old.&#xD;
&#xD;
          -  Clinically diagnosed osteoarthritis before treatment.&#xD;
&#xD;
          -  Patient with refractory active osteoarthritis (not responding to treatment).&#xD;
&#xD;
          -  Ability to sleep in fixed position for about 25 minutes&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient above 30 years old.&#xD;
&#xD;
          -  Clinically diagnosed osteoarthritis before treatment.&#xD;
&#xD;
          -  Patient with refractory active osteoarthritis (not responding to treatment).&#xD;
&#xD;
          -  Ability to sleep in fixed position for about 25 minutes&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with resolved osteoarthritis.&#xD;
&#xD;
          -  patient with other disease in joints:&#xD;
&#xD;
               -  Avascular necrosis&#xD;
&#xD;
               -  Stress fracture&#xD;
&#xD;
               -  Neuropathic pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fatma- Elzahraa Mostafa mahmoud</last_name>
    <phone>01095529911</phone>
    <email>fatma.mostafa07@gmail.com</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Fatma El-Zahraa Mostafa Mahmoud</investigator_full_name>
    <investigator_title>resident physicians</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03290807
org study id: SPECT/CT in osteoarthritis
nct id: NCT03290807
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether
      it is related to clinical findings and it could reflect clinical disease activity, and to
      determine the usefulness of SPECT/CT in early detection of OA.
Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses
      over years. After the classification and reporting of OA were established by American College
      of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported
      by plain radiographic findings.

      Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend
      to depend on the clinical symptoms, rather than the objective imaging findings.

      MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as
      bone marrow oedema, but it has some limitation in that it may have false positive or false
      negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is
      relatively sensitive because it reflects the early physiological changes of joints. But its
      image is planar that it cannot give enough information for the anatomic localization, and the
      image is overlapped.

      To compensate for the defects of these imaging methods, bone single photon emission computed
      tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.

      Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone
      SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.

      The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional
      imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and
      follow-up after procedures.
observational model: Cohort
time perspective: Prospective
measure: Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings.
time frame: Baseline
description: Osteoarthritic patients will be examined with 99mTc-methylene diphosphonate (MDP) bone SPECT, the sites of uptake will be localized.
Simple radiograph and physical examination will be assessed.The relationships between clinical findings, simple radiographic findings and the intensity of uptake in SPECT will be analyzed.
intervention type: Device
intervention name: SPECT/CT
description: Combined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Fatma- Elzahraa Mostafa mahmoud
phone: 01095529911
email: fatma.mostafa07@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Fatma El-Zahraa Mostafa Mahmoud
investigator title: resident physicians
mesh term: Osteoarthritis