<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/NCT03756077</url>
  </required_header>
  <id_info>
    <org_study_id>XLan</org_study_id>
    <nct_id>NCT03756077</nct_id>
  </id_info>
  <brief_title>A Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer</brief_title>
  <official_title>A Prospective Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</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>
      According to the latest data from the China National Cancer Center, prostate cancer has&#xD;
      become the most common tumor in the urinary system since 2008. However, conventional imaging&#xD;
      techniques including transrectal ultrasound , computed tomography and bone scintigraphy are&#xD;
      not sensitive or specific. About 40% of resectable lesions cannot be detected by these&#xD;
      techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and&#xD;
      staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new&#xD;
      novel positron tracer has shown to be effective to detect primary lesions, recurrent and&#xD;
      metastatic lesions of prostate cancer. In this prospective study, the investigators will use&#xD;
      the most advanced imaging equipments, integrated PET/MR, and PET/CT with prostate&#xD;
      cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent&#xD;
      [F-18]fluorodeoxyglucose to image patients with or suspected of prostate cancer, the aim is&#xD;
      to explore the value of hybrid PET/MR and PET/CT in prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the latest data from the China National Cancer Center, prostate cancer has&#xD;
      become the most common tumor in the urinary system since 2008. However, conventional imaging&#xD;
      techniques including transrectal ultrasound , computed tomography and bone scintigraphy are&#xD;
      not sensitive or specific. About 40% of resectable lesions cannot be detected by these&#xD;
      techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and&#xD;
      staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new&#xD;
      novel positron tracer has shown to be effective to detect primary lesions, recurrence and&#xD;
      metastatic lesions of prostate cancer. In this prospective study, the investigators will use&#xD;
      the most advanced imaging equipment, integrated PET/MR, and PET/CT with prostate&#xD;
      cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent&#xD;
      [F-18]fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with&#xD;
      prostate cancer, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT&#xD;
      in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging&#xD;
      and determining treatment plan prior to treatment; for the patients with a history of&#xD;
      prostate cancer, the aim is to evaluate the value of integrated PET/MR and PET/CT for&#xD;
      treatment response assessment, detection of recurrences and metastatic lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging</measure>
    <time_frame>up to 2 years</time_frame>
    <description>For patient without any treatment, Initial diagnosis and staging results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection</measure>
    <time_frame>up to 2 years</time_frame>
    <description>For patient with a history of prostate cancer, results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites</measure>
    <time_frame>up to 2 years</time_frame>
    <description>For patient with a history of prostate cancer and suspected of recurrence, evaluate Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for different PSA levels, different lesion sites</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>PET/MR</condition>
  <condition>PET/CT</condition>
  <arm_group>
    <arm_group_label>Primary diagnosis and staging</arm_group_label>
    <description>Patients suspected of or diagnosed with prostate cancer who want a differential diagnosis and staging by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT before treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evaluation of recurrence</arm_group_label>
    <description>Patients with a history of prostate cancer and elevated PSA level after treatment, who need to determining whether or not there are recurrences/metastatic lesions and its locations by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT</intervention_name>
    <description>0.05-0.06 mCi per kilogram bodyweight of 68Ga-PSMA, 0.1-0.15 mCi per kilogram bodyweight of 18F-FDG will be injected intravenously prior to imaging</description>
    <arm_group_label>Evaluation of recurrence</arm_group_label>
    <arm_group_label>Primary diagnosis and staging</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Central China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suspected of or diagnosed with prostate cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute systemic diseases and electrolyte disorders&#xD;
&#xD;
          -  Patients with known malignancy in other organs&#xD;
&#xD;
          -  Patients with severe claustrophobia or unstable vital sigh&#xD;
&#xD;
          -  Other serious comorbidities evaluated by primary investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoli Lan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoli Lan, MD, PhD</last_name>
    <phone>+86-13886193262</phone>
    <email>lxl730724@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiaoli Lan</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoli Lan</last_name>
      <phone>+86-13886193262</phone>
      <email>lxl730724@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Xiaoli Lan</investigator_full_name>
    <investigator_title>Director of the Department of nuclear medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03756077
org study id: XLan
nct id: NCT03756077
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
According to the latest data from the China National Cancer Center, prostate cancer has
      become the most common tumor in the urinary system since 2008. However, conventional imaging
      techniques including transrectal ultrasound , computed tomography and bone scintigraphy are
      not sensitive or specific. About 40% of resectable lesions cannot be detected by these
      techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and
      staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new
      novel positron tracer has shown to be effective to detect primary lesions, recurrent and
      metastatic lesions of prostate cancer. In this prospective study, the investigators will use
      the most advanced imaging equipments, integrated PET/MR, and PET/CT with prostate
      cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent
      [F-18]fluorodeoxyglucose to image patients with or suspected of prostate cancer, the aim is
      to explore the value of hybrid PET/MR and PET/CT in prostate cancer.
According to the latest data from the China National Cancer Center, prostate cancer has
      become the most common tumor in the urinary system since 2008. However, conventional imaging
      techniques including transrectal ultrasound , computed tomography and bone scintigraphy are
      not sensitive or specific. About 40% of resectable lesions cannot be detected by these
      techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and
      staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new
      novel positron tracer has shown to be effective to detect primary lesions, recurrence and
      metastatic lesions of prostate cancer. In this prospective study, the investigators will use
      the most advanced imaging equipment, integrated PET/MR, and PET/CT with prostate
      cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent
      [F-18]fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with
      prostate cancer, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT
      in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging
      and determining treatment plan prior to treatment; for the patients with a history of
      prostate cancer, the aim is to evaluate the value of integrated PET/MR and PET/CT for
      treatment response assessment, detection of recurrences and metastatic lesions.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging
time frame: up to 2 years
description: For patient without any treatment, Initial diagnosis and staging results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.
measure: Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection
time frame: up to 2 years
description: For patient with a history of prostate cancer, results of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT will be compared to pathology, clinical and follow-up result. Evaluation of the concordance between 68Ga-PSMA PET/MR and PET/CT, the differences between 68Ga-PSMA and 18F-FDG.
measure: Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites
time frame: up to 2 years
description: For patient with a history of prostate cancer and suspected of recurrence, evaluate Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for different PSA levels, different lesion sites
arm group label: Primary diagnosis and staging
description: Patients suspected of or diagnosed with prostate cancer who want a differential diagnosis and staging by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT before treatment
arm group label: Evaluation of recurrence
description: Patients with a history of prostate cancer and elevated PSA level after treatment, who need to determining whether or not there are recurrences/metastatic lesions and its locations by 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT
intervention type: Diagnostic Test
intervention name: 68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT
description: 0.05-0.06 mCi per kilogram bodyweight of 68Ga-PSMA, 0.1-0.15 mCi per kilogram bodyweight of 18F-FDG will be injected intravenously prior to imaging
arm group label: Evaluation of recurrence
arm group label: Primary diagnosis and staging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaoli Lan, MD, PhD
role: Principal Investigator
affiliation: Wuhan Union Hospital, China
last name: Xiaoli Lan, MD, PhD
phone: +86-13886193262
email: lxl730724@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Xiaoli Lan
investigator title: Director of the Department of nuclear medicine
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: Undecided