<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/NCT03033485</url>
  </required_header>
  <id_info>
    <org_study_id>KY20151230-1</org_study_id>
    <nct_id>NCT03033485</nct_id>
  </id_info>
  <brief_title>18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis</brief_title>
  <official_title>18F-Labeled Picolinamide PET-CT in the Management of Patients With Melanoma: The Radiation Dosimetry and Diagnostic Applications in Melanoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the dosimetric properties of the positron emission&#xD;
      tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily&#xD;
      evaluate its diagnosis value in melanoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 patients with pathology diagnosed melanoma will be enrolled for the clinical study. If&#xD;
      agree to take part in this study, the patient will be performed with 18F-P3BZA PET/CT scan&#xD;
      and 18F-FDG PET/CT scan in the other day before and after surgery. Next, all of the resected&#xD;
      tissues from the patients will be checked with pathology.&#xD;
&#xD;
      6 of 50 patients are performed for whole-body PET scans at 0, 15, 30, 45, 60, and 120 minutes&#xD;
      and a CT scan at 60 minutes after tracer injection (mean dose, 5.0 ± 0.5 mCi in 2.0 ± 0.5ml)&#xD;
      will be performed. During the imaging period, 1 mL blood samples will be obtained for&#xD;
      time-activity curve calculations at 1, 5, 10, 30,60, 90, 120, and 180 minutes after&#xD;
      injection. The estimated radiation doses will be calculated by using OLINDA/EXM software.&#xD;
&#xD;
      The images produced by these scans will be compared to see the diagnosis value of 18F-P3BZA.&#xD;
&#xD;
      Screening Tests:&#xD;
&#xD;
      Women who decide to take part in this study will be asked if they think they might be&#xD;
      pregnant at the start of the study. All of them must have a negative blood pregnancy test&#xD;
      (Human chorionic gonadotropin, HCG).&#xD;
&#xD;
      PET-CT Scan Procedure:&#xD;
&#xD;
      Before the PET-CT scan is performed, patient will be asked to remove any metallic objects&#xD;
      when she/he arrive at the PET-CT Center. After a property rest, he/she will be injected with&#xD;
      about 5mCi 18F-P3BZA. The first scan will take at 60 minutes after injection and a delay scan&#xD;
      will take at 120 minutes after injection. Each PET/CT scan will take about 20 minutes.&#xD;
&#xD;
      After 18F-P3BZA scan, the patient will be asked to avoid stressful exercise. Starting about&#xD;
      12 hours before 18F-FDG scan, he/she will be asked to limit the amount of carbohydrates until&#xD;
      the scans are done.&#xD;
&#xD;
      Follow-Up Visits:&#xD;
&#xD;
      Patients' primary care physician will follow-up them for next 24 hours. After then, they may&#xD;
      order additional imaging or surgical results after this study for follow-up purposes. The&#xD;
      study doctor will review these results to compare them with the PET-CT images. The study&#xD;
      doctors will also review the results of any biopsies you may have had as a result of PET-CT&#xD;
      findings.&#xD;
&#xD;
      This is an investigational study. PET-CT and CT scans are FDA approved and commercially&#xD;
      available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <phase>N/A</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>SUV of organs and melanoma</measure>
    <time_frame>1 hour after injection</time_frame>
    <description>The maximum standardized uptake values (SUVmax) with unit of g/mL of 18F-P3BZA and 18F-FDG in melanoma tissues.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Melanoma patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Melanoma patients enrolled for the clinical diagnosis study are performed with both 18F-P3BZA PET/CT and18F-FDG PET/CT scans before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-P3BZA</intervention_name>
    <description>18F-P3BZA is a type of 18F labeled Picolinamide targeting melanin which is highly secreted in Melanoma. The toxicity of P3BZA was evaluated by SoBran Bioscience. The final report showed that there no signs of toxicity during the conduct of the toxicity study. No treatment-related differences were noted in mean body weight and body weight changes, clinical chemistry, haematology, or coagulation parameter after a single intravenous dose of P3BZA at 0.0589mg/kg.</description>
    <arm_group_label>Melanoma patients</arm_group_label>
    <other_name>18F labeled Picolinamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with melanoma: diagnosed by pathology and ready for surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with melanoma: refuse or cannot endure surgery&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jing Wang, M.D, Ph.D</last_name>
    <phone>86-29-84775449</phone>
    <email>wangjing@fmmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaowei Ma, M.D</last_name>
    <phone>86-29-84771048</phone>
    <email>mxw_cn@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing Hospital Nuclear Medicine Department</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Picolinamide</keyword>
  <keyword>PET/CT</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</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/NCT03033485
org study id: KY20151230-1
nct id: NCT03033485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the dosimetric properties of the positron emission
      tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily
      evaluate its diagnosis value in melanoma patients.
50 patients with pathology diagnosed melanoma will be enrolled for the clinical study. If
      agree to take part in this study, the patient will be performed with 18F-P3BZA PET/CT scan
      and 18F-FDG PET/CT scan in the other day before and after surgery. Next, all of the resected
      tissues from the patients will be checked with pathology.

      6 of 50 patients are performed for whole-body PET scans at 0, 15, 30, 45, 60, and 120 minutes
      and a CT scan at 60 minutes after tracer injection (mean dose, 5.0 ± 0.5 mCi in 2.0 ± 0.5ml)
      will be performed. During the imaging period, 1 mL blood samples will be obtained for
      time-activity curve calculations at 1, 5, 10, 30,60, 90, 120, and 180 minutes after
      injection. The estimated radiation doses will be calculated by using OLINDA/EXM software.

      The images produced by these scans will be compared to see the diagnosis value of 18F-P3BZA.

      Screening Tests:

      Women who decide to take part in this study will be asked if they think they might be
      pregnant at the start of the study. All of them must have a negative blood pregnancy test
      (Human chorionic gonadotropin, HCG).

      PET-CT Scan Procedure:

      Before the PET-CT scan is performed, patient will be asked to remove any metallic objects
      when she/he arrive at the PET-CT Center. After a property rest, he/she will be injected with
      about 5mCi 18F-P3BZA. The first scan will take at 60 minutes after injection and a delay scan
      will take at 120 minutes after injection. Each PET/CT scan will take about 20 minutes.

      After 18F-P3BZA scan, the patient will be asked to avoid stressful exercise. Starting about
      12 hours before 18F-FDG scan, he/she will be asked to limit the amount of carbohydrates until
      the scans are done.

      Follow-Up Visits:

      Patients' primary care physician will follow-up them for next 24 hours. After then, they may
      order additional imaging or surgical results after this study for follow-up purposes. The
      study doctor will review these results to compare them with the PET-CT images. The study
      doctors will also review the results of any biopsies you may have had as a result of PET-CT
      findings.

      This is an investigational study. PET-CT and CT scans are FDA approved and commercially
      available.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUV of organs and melanoma
time frame: 1 hour after injection
description: The maximum standardized uptake values (SUVmax) with unit of g/mL of 18F-P3BZA and 18F-FDG in melanoma tissues.
arm group label: Melanoma patients
arm group type: Experimental
description: Melanoma patients enrolled for the clinical diagnosis study are performed with both 18F-P3BZA PET/CT and18F-FDG PET/CT scans before surgery.
intervention type: Radiation
intervention name: 18F-P3BZA
description: 18F-P3BZA is a type of 18F labeled Picolinamide targeting melanin which is highly secreted in Melanoma. The toxicity of P3BZA was evaluated by SoBran Bioscience. The final report showed that there no signs of toxicity during the conduct of the toxicity study. No treatment-related differences were noted in mean body weight and body weight changes, clinical chemistry, haematology, or coagulation parameter after a single intravenous dose of P3BZA at 0.0589mg/kg.
arm group label: Melanoma patients
other name: 18F labeled Picolinamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jing Wang, M.D, Ph.D
phone: 86-29-84775449
email: wangjing@fmmu.edu.cn
last name: Xiaowei Ma, M.D
phone: 86-29-84771048
email: mxw_cn@hotmail.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Melanoma
sharing ipd: No