<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230703058654N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-22</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating diagnostic value of 99mTc-CXCR4 scan in glioblastoma</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating diagnostic value of 99mTc-CXCR4 scan in differentiation of high-grade and low-grade glioma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73013</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Glioblastoma.</hc_freetext>
      <i_freetext>The intervention groups include glioblastoma patients whose mass has been proven by imaging methods such as MRI. This evaluation is a diagnostic method using the single photon emission computed tomography (SPECT) modality, in which the radiopharmaceutical 99mTCc-CXCR4 is injected into patients at a dose of 20 millicuries. The CXCR4 peptide is produced as a kit by the Atomic Energy Organization and all chemical and bacterial purity tests are checked on it. The desired radiopharmaceutical is labeled in Namazi Hospital, Shiraz, and its radiochemical purity is checked and confirmed before injection to the patient. This radiopharmaceutical is injected intravenously to patients once. The place of injection is the nuclear medicine department of Shiraz Namazi Hospital, where there are necessary medical equipment and also a doctor for prevention and treatment in case the patient has complications caused by the injection. The results of the imaging are finally compared with the pathology results after surgery..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. tahereh firuzyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi hospital, Namazi Square, Zand St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613311</zip>
        <telephone>+98 71 3612 5387</telephone>
        <email>firuzyar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tahereh Ghaedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi hospital, Namazi Square, Zand St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613311</zip>
        <telephone>+98 71 3612 5315</telephone>
        <email>tghaedian@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient has been diagnosed with glioma based on MRI within the last month
The patient is a candidate for surgical resection and has not undergone any type of anti-cancer treatment
The patient's condition is stable for the scan
The patient consents to the scan, and at the time of the scan
Do not be pregnant or breastfeeding</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with multiple masses
Patients who need emergency interventions after initial diagnosis
Patients whose tumor cannot be operated
Patients who do not consent to scan or surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C71.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of brain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention groups include glioblastoma patients whose mass has been proven by imaging methods such as MRI. This evaluation is a diagnostic method using the single photon emission computed tomography (SPECT) modality, in which the radiopharmaceutical 99mTCc-CXCR4 is injected into patients at a dose of 20 millicuries. The CXCR4 peptide is produced as a kit by the Atomic Energy Organization and all chemical and bacterial purity tests are checked on it. The desired radiopharmaceutical is labeled in Namazi Hospital, Shiraz, and its radiochemical purity is checked and confirmed before injection to the patient. This radiopharmaceutical is injected intravenously to patients once. The place of injection is the nuclear medicine department of Shiraz Namazi Hospital, where there are necessary medical equipment and also a doctor for prevention and treatment in case the patient has complications caused by the injection. The results of the imaging are finally compared with the pathology results after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mean amount of radioactivity uptake in low-grade glioma patients. Timepoint: 3 hours after radiopharmaceutical administration. Method of measurement: SPECT/CT imaging.</prim_outcome>
      <prim_outcome>The mean amount of radioactivity uptake in high-grade glioma patients. Timepoint: 3 hours after radiopharmaceutical administration. Method of measurement: SPECT/CT imaging.</prim_outcome>
      <prim_outcome>Sensitivity of imaging to detect high-grade glioma. Timepoint: 3 hours after radiopharmaceutical administration. Method of measurement: SPECT/CT imaging and comparison with pathology results.</prim_outcome>
      <prim_outcome>Sensitivity of imaging to detect low-grade glioma. Timepoint: 3 hours after radiopharmaceutical administration. Method of measurement: SPECT/CT imaging and comparison with pathology results.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Nuclear Science and Technology Research Institute</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
      <source_name>Nuclear Science and Technology Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-03</approval_date>
        <contact_name>Expert Committee on Ethics in Biomedical Research, Faculty of Medicine, Shiraz University of Medical</contact_name>
        <contact_address>Vice-Chancellor of the Medical School, 3rd Floor, Building No. 3, School of Medicine, Imam Hossein square, Zand St. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
