<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/NCT04504526</url>
  </required_header>
  <id_info>
    <org_study_id>FirstAHFMUCXCR4</org_study_id>
    <nct_id>NCT04504526</nct_id>
  </id_info>
  <brief_title>Value of Chemokine Receptor CXCR4 Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases</brief_title>
  <official_title>Value of Chemokine Receptor CXCR4-targeting Molecular Imaging for Diagnosis and Prognostic Evaluation in Lymphoproliferative Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Fujian Medical 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>
      Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes,&#xD;
      macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells&#xD;
      (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in&#xD;
      vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic&#xD;
      malignancies. This prospective study is going to investigate whether metabolic&#xD;
      characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk&#xD;
      stratification, and the prognostic evaluation in lymphoproliferative diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphoma:&#xD;
&#xD;
      The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present&#xD;
      with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4&#xD;
      expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective&#xD;
      and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is&#xD;
      going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic&#xD;
      evaluation of CXCR4 expression in lymphoma.&#xD;
&#xD;
      Multiple myeloma:&#xD;
&#xD;
      Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells&#xD;
      producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important&#xD;
      predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status&#xD;
      because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed&#xD;
      Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular&#xD;
      imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM&#xD;
      with higher accuracy. This prospective study is going to investigate the value of&#xD;
      68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.&#xD;
&#xD;
      Leukemia： Leukemia is the second largest family of hematological malignancies after the&#xD;
      lymphomas, and, depending on the subtype, may show a considerable overlap of histological&#xD;
      features with the latter. The four main kinds of leukemia are, in the order of their&#xD;
      prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with&#xD;
      regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for&#xD;
      routine evaluation of CLL, because the disease shows low uptake in the majority of cases.&#xD;
      Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that&#xD;
      are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal&#xD;
      symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become&#xD;
      more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is&#xD;
      known to be associated with poor prognosis in CLL. Recently, the feasibility of&#xD;
      68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is&#xD;
      going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic&#xD;
      evaluation of CXCR4 expression in leukemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Early Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUVmax</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The time for patient's survival</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic sensitivity and specficity in special type of lymphoma</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lymphoma</condition>
  <condition>Multiple Myeloma</condition>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>68Ga-Pentixafor, PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET/CT perform after injecting 68Ga-Pentixafor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-Pentixafor</intervention_name>
    <description>Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.</description>
    <arm_group_label>68Ga-Pentixafor, PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suspected or confirmed untreated Lymphoproliferative diseases patients&#xD;
&#xD;
          -  18F-FDG PET/CT within two weeks&#xD;
&#xD;
          -  signed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  known allergy against Pentixafor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weibing Miao, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Fujian Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weibing Miao, M.D.</last_name>
    <phone>+86-599-87981618</phone>
    <email>miaoweibing@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenying Chen</last_name>
    <phone>+86-599-87981619</phone>
    <email>chenzhenying726@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weibing Miao, MD</last_name>
      <phone>+86 591 87981618</phone>
      <email>miaoweibing@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhenying Chen, MB</last_name>
      <phone>+86 591 87981619</phone>
      <email>714144972@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Fujian Medical University</investigator_affiliation>
    <investigator_full_name>Weibing Miao, PhD</investigator_full_name>
    <investigator_title>Director of Nuclear Medicine Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Lymphoproliferative Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04504526
org study id: FirstAHFMUCXCR4
nct id: NCT04504526
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chemokine receptor CXCR4 is normally expressed on T-lymphocytes, B-lymphocytes, monocytes,
      macrophages, neutrophils and eosinophils as well as hematopoietic stem and progenitor cells
      (HSPC) in the bone marrow. 68Ga-Pentixafor PET/CT represents a promising method for the in
      vivo assessment of the CXCR4 expression status in cancer patients, especially in hematologic
      malignancies. This prospective study is going to investigate whether metabolic
      characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk
      stratification, and the prognostic evaluation in lymphoproliferative diseases.
Lymphoma:

      The marginal zone lymphoma, plasma cell lymphoma, T-cell-lymphoma frequently do not present
      with an elevated FDG uptake. However, lymphoma is a frequent cancer with high CXCR4
      expression. The previous studies showed 68Ga-pentixafor-PET seems to be a highly selective
      and specific method for the in vivo quantification of CXCR4 expression. Thus, our study is
      going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis and prognostic
      evaluation of CXCR4 expression in lymphoma.

      Multiple myeloma:

      Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells
      producing a monoclonal immunoglobulin. Minimal residual disease (MRD) status is an important
      predictor of clinical outcome in MM. But it is difficult to assess the accurate MRD status
      because of the significant heterogeneity characterizing with 18F-FDG PET/CT. Studies showed
      Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular
      imaging-68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM
      with higher accuracy. This prospective study is going to investigate the value of
      68Ga-Pentixafor PET/CT for the diagnosis and prognostic evaluation of CXCR4 expression in MM.

      Leukemia： Leukemia is the second largest family of hematological malignancies after the
      lymphomas, and, depending on the subtype, may show a considerable overlap of histological
      features with the latter. The four main kinds of leukemia are, in the order of their
      prevalence. Imaging has traditionally played a limited role in the work-up of leukemias, with
      regard to detection, staging, and response assessment. 18F-FDG PET/CT is not recommended for
      routine evaluation of CLL, because the disease shows low uptake in the majority of cases.
      Although, the clinical utility of MRI lies in the detection of bone marrow abnormalities that
      are suspicious for leukemia in adult and pediatric patients with unclear musculoskeletal
      symptoms with its reduced radiation dose (in comparison with PET/CT). However, it may become
      more attractive with the use of newer, non-FDG PET radiotracers. High CXCR4 expression is
      known to be associated with poor prognosis in CLL. Recently, the feasibility of
      68Ga-Pentixafor PET has also been demonstrated for CLL and AML. This prospective study is
      going to investigate the value of 68Ga-Pentixafor PET/CT for the diagnosis and prognostic
      evaluation of CXCR4 expression in leukemia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax
time frame: through study completion, an average of 3 years
description: SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the liver, and/or mediastinal blood pool, and/or L3 vertebra are defined as the background.
measure: The time for patient's survival
time frame: through study completion, an average of 3 years
description: Investigators follow up and record the time for patient's survival. To investigate the ralationship between initial SUVmax of focal lesions and survival. Finally, the prognostic evaluation of 68Ga-Pentixafor PET/CT for lymphoproliferative diseases in comparison with 18F-FDG PET/CT.
measure: Diagnostic sensitivity and specficity in special type of lymphoma
time frame: through study completion, an average of 3 years
arm group label: 68Ga-Pentixafor, PET/CT
arm group type: Experimental
description: PET/CT perform after injecting 68Ga-Pentixafor
intervention type: Drug
intervention name: 68Ga-Pentixafor
description: Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.
arm group label: 68Ga-Pentixafor, PET/CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Weibing Miao, M.D.
role: Principal Investigator
affiliation: First Affiliated Hospital of Fujian Medical University
last name: Weibing Miao, M.D.
phone: +86-599-87981618
email: miaoweibing@126.com
last name: Zhenying Chen
phone: +86-599-87981619
email: chenzhenying726@foxmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Fujian Medical University
investigator full name: Weibing Miao, PhD
investigator title: Director of Nuclear Medicine Department
mesh term: Multiple Myeloma
mesh term: Lymphoproliferative Disorders
sharing ipd: No