<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/NCT03768479</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2016-020</org_study_id>
    <nct_id>NCT03768479</nct_id>
  </id_info>
  <brief_title>The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer</brief_title>
  <acronym>PET</acronym>
  <official_title>The Value of 18F-FES-PET/CT in Predicting the Efficacy of Fulvestrant as First-line Treatment in Postmenopausal Patients With Hormone Receptor-positive Advanced Breast Cancer - a Multicenter Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in&#xD;
      hormone receptor-positive breast cancer. The imaging agent involved in this study is&#xD;
      16α-[18F]-fluoro-17β-estradiol (18F-FES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open, multi-center and prospective clinical study, It is the first time&#xD;
      investigators are examining this imaging agent in Chinese patients with breast cancer.&#xD;
&#xD;
      The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research&#xD;
      studies. The Chinese FDA has not approved this tracer for any use outside of research. In&#xD;
      this research study, the investigators are investigating the use of a PET tracer called&#xD;
      18F-FES in patients with breast cancer.&#xD;
&#xD;
      The purpose is to take images that can measure the amount of a protein called Estrogen&#xD;
      Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the&#xD;
      Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures&#xD;
      of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the&#xD;
      tracer before and after the first cycle of Fulvestrant treatment. The investigators are&#xD;
      trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount&#xD;
      change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment.&#xD;
&#xD;
      This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic&#xD;
      levels of ER in advance, and potentially help guide treatment of breast tumors in the future.&#xD;
&#xD;
      18F-FES was initially developed to image the primary breast tumor. In previous studies of&#xD;
      18F-FES conducted in humans, there were no adverse events (there have been no problems).&#xD;
      While this is not the first time 18F-FES has been used in humans, it is the first study in&#xD;
      which the investigators study its predictive value in the treatment efficacy in breast&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 5, 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">December 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change percentage of 18F-FES SUV</measure>
    <time_frame>At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)</time_frame>
    <description>The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between the change percentage of 18F-FES SUV and the clinical efficacy</measure>
    <time_frame>From the enrollment time to the time of disease progression or 2 years' followup which comes first</time_frame>
    <description>To find the correlation between the change percentage of 18F-FES SUV and the clinical efficacy, and further to determine the cutoff of 18F-FES SUV change percentage that could predict beneficial efficacy of Fulvestrant in breast cancer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>clinical efficacy: RECIST criteria</measure>
    <time_frame>From the enrollment time to the time of disease progression or 2 years' followup which comes first</time_frame>
    <description>The therapeutic efficacy of Fulvestrant in breast cancer patients, record as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to RECIST criteria</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Estrogen Receptor-positive Breast Cancer</condition>
  <condition>Fulvestrant</condition>
  <arm_group>
    <arm_group_label>FES-Fulvestrant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>18F-FES-PET</intervention_name>
    <description>18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant</description>
    <arm_group_label>FES-Fulvestrant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years or older (required for legal consent)&#xD;
&#xD;
          -  Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%,&#xD;
             see Appendix A)&#xD;
&#xD;
          -  Pathologically diagnosed metastatic breast cancer&#xD;
&#xD;
          -  Fulvestrant used as the first-line treatment&#xD;
&#xD;
          -  Have primary breast tumor that is at least 2 cm in diameter as measured in any&#xD;
             dimension on either mammogram, ultrasound, or breast MRI&#xD;
&#xD;
          -  Have the ability to understand and the willingness to sign a written informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          -  Previously treated metastatic breast cancer&#xD;
&#xD;
          -  Concurrent malignancy of any type&#xD;
&#xD;
          -  Impaired elimination (as defined as having problems with urination)&#xD;
&#xD;
          -  Participation in a research study/studies involving radiation exposure within the past&#xD;
             12 months&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, major kidney or liver disease, or psychiatric illness/social situations&#xD;
             that would limit compliance with study requirements&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Currently lactating (either breast feeding or breast pumping)&#xD;
&#xD;
        General PET/CT Safety Exclusion Criteria:&#xD;
&#xD;
          -  Electrical implants such as cardiac pacemakers or perfusion pumps&#xD;
&#xD;
          -  Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial&#xD;
             hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere&#xD;
             on the body, tattoos near the eye, steel implants, ferromagnetic objects such as&#xD;
             jewelry or metal clips in clothing&#xD;
&#xD;
          -  Pre-existing medical conditions including a likelihood of developing seizures or&#xD;
             claustrophobic reactions, and any greater than normal potential for cardiac arrest&#xD;
&#xD;
          -  Inability to lie comfortably on a bed inside a PET camera for 90 minutes as assessed&#xD;
             by physical examination and medical history (e.g. back pain, arthritis)&#xD;
&#xD;
          -  Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure&#xD;
             for female subjects of child-bearing age.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Xi'an Jiaotong U</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin Jin</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Xi'an Jiaotong U</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Yang</last_name>
    <phone>0086-029-85324600</phone>
    <email>yangjin@xjtu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin Jin</last_name>
    <phone>0086-029-85324600</phone>
    <email>yangjin@xjtu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Yang</last_name>
      <phone>0086-029-85324600</phone>
      <email>yangjin@xjtu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.</citation>
    <PMID>25380844</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_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/NCT03768479
org study id: XJTU1AF-CRF-2016-020
nct id: NCT03768479
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in
      hormone receptor-positive breast cancer. The imaging agent involved in this study is
      16α-[18F]-fluoro-17β-estradiol (18F-FES).
This study is an open, multi-center and prospective clinical study, It is the first time
      investigators are examining this imaging agent in Chinese patients with breast cancer.

      The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research
      studies. The Chinese FDA has not approved this tracer for any use outside of research. In
      this research study, the investigators are investigating the use of a PET tracer called
      18F-FES in patients with breast cancer.

      The purpose is to take images that can measure the amount of a protein called Estrogen
      Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the
      Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures
      of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the
      tracer before and after the first cycle of Fulvestrant treatment. The investigators are
      trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount
      change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment.

      This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic
      levels of ER in advance, and potentially help guide treatment of breast tumors in the future.

      18F-FES was initially developed to image the primary breast tumor. In previous studies of
      18F-FES conducted in humans, there were no adverse events (there have been no problems).
      While this is not the first time 18F-FES has been used in humans, it is the first study in
      which the investigators study its predictive value in the treatment efficacy in breast
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: the change percentage of 18F-FES SUV
time frame: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)
description: The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment
measure: The correlation between the change percentage of 18F-FES SUV and the clinical efficacy
time frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first
description: To find the correlation between the change percentage of 18F-FES SUV and the clinical efficacy, and further to determine the cutoff of 18F-FES SUV change percentage that could predict beneficial efficacy of Fulvestrant in breast cancer
measure: clinical efficacy: RECIST criteria
time frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first
description: The therapeutic efficacy of Fulvestrant in breast cancer patients, record as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to RECIST criteria
arm group label: FES-Fulvestrant
arm group type: Experimental
description: Patients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant.
intervention type: Device
intervention name: 18F-FES-PET
description: 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
arm group label: FES-Fulvestrant
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jin Yang
role: Principal Investigator
affiliation: First Affiliated Hospital of Xi'an Jiaotong U
last name: Jin Jin
role: Principal Investigator
affiliation: First Affiliated Hospital of Xi'an Jiaotong U
last name: Jin Yang
phone: 0086-029-85324600
email: yangjin@xjtu.edu.cn
last name: Jin Jin
phone: 0086-029-85324600
email: yangjin@xjtu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.
PMID: 25380844
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided