<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/NCT02204462</url>
  </required_header>
  <id_info>
    <org_study_id>J13162</org_study_id>
    <secondary_id>NA_00084913</secondary_id>
    <nct_id>NCT02204462</nct_id>
  </id_info>
  <brief_title>FBnTP Imaging of Breast Cancer</brief_title>
  <official_title>FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our preclinical studies suggest the capacity of the positron emission tomography imaging&#xD;
      agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast&#xD;
      tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy&#xD;
      than that obtained by existing breast imaging tools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the most widespread type of cancer among women in the USA, and the second&#xD;
      leading cause of death. The National Cancer Institute estimates that in 2013, in the USA,&#xD;
      226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast&#xD;
      cancer, most of them of progressive metastatic disease. Early detection and treatment of the&#xD;
      disease, when the tumor is still localized and at a high curability state, is the outmost&#xD;
      important determinant of disease-free survival of breast cancer patients. Survival rate of&#xD;
      women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ-&#xD;
      DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early&#xD;
      detection of breast cancer is relatively poor. This is best exemplify by the astonishing&#xD;
      percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3&#xD;
      billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure&#xD;
      DCIS.&#xD;
&#xD;
      Our preclinical studies suggest the capacity of the positron emission tomography (PET)&#xD;
      imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small&#xD;
      breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better&#xD;
      accuracy than that obtained by existing breast imaging tools. Accordingly, the present&#xD;
      protocol is designed to extend the preclinical findings into clinical studies in breast&#xD;
      cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant&#xD;
      lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lock of funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 12, 2015</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 13, 2021</primary_completion_date>
  <phase>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>Malignant breast cancer detection</measure>
    <time_frame>Pre-treatment</time_frame>
    <description>A feasibility study to assess the capacity of 18F-FBnTP PEM to detect and localize malignant breast lesions. Histopathology results will serve as reference standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Imaging comparison</measure>
    <time_frame>Pre-treatment</time_frame>
    <description>To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests such as mammogram, 18F-FDG PEM or MRI.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Newly diagnosed breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e. index cancer). Patients will undergo FBnTP PET imaging for detection of malignant breast cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FBnTP</intervention_name>
    <description>A PET imaging radiotracer</description>
    <arm_group_label>Newly diagnosed breast cancer</arm_group_label>
    <other_name>Fluorobenzyl triphenyl phosphonium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with newly-diagnosed invasive and/or intraductal breast cancer&#xD;
             detected by core needle or vacuum-assisted biopsy (i.e., index cancer)&#xD;
&#xD;
          -  Age &gt; 25 Ability and willingness to sign informed consent prior to any study&#xD;
             procedure.&#xD;
&#xD;
          -  Positive indication of disease on mammogram or MRI scan.&#xD;
&#xD;
          -  Candidate for breast cancer surgery on the basis of recommendation of a breast cancer&#xD;
             surgeon.&#xD;
&#xD;
          -  Ability to undergo up to 90 minutes of PEM imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active or chronic illness that, in the opinion of the investigators, would make&#xD;
             the study unsafe or limit compliance with study procedures.&#xD;
&#xD;
          -  Past or present history of active substance abuse (drug or alcohol).&#xD;
&#xD;
          -  Inability to tolerate venous access.&#xD;
&#xD;
          -  Pregnant females are excluded from this study. All females of child-bearing potential&#xD;
             will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Pomper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PET</keyword>
  <keyword>Positron Emission Tomography</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Imaging</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>via manuscripts publication</ipd_description>
  </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/NCT02204462
org study id: J13162
secondary id: NA_00084913
nct id: NCT02204462
lead sponsor: 
has dmc: No
Our preclinical studies suggest the capacity of the positron emission tomography imaging
      agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast
      tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy
      than that obtained by existing breast imaging tools.
Breast cancer is the most widespread type of cancer among women in the USA, and the second
      leading cause of death. The National Cancer Institute estimates that in 2013, in the USA,
      226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast
      cancer, most of them of progressive metastatic disease. Early detection and treatment of the
      disease, when the tumor is still localized and at a high curability state, is the outmost
      important determinant of disease-free survival of breast cancer patients. Survival rate of
      women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ-
      DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early
      detection of breast cancer is relatively poor. This is best exemplify by the astonishing
      percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3
      billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure
      DCIS.

      Our preclinical studies suggest the capacity of the positron emission tomography (PET)
      imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small
      breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better
      accuracy than that obtained by existing breast imaging tools. Accordingly, the present
      protocol is designed to extend the preclinical findings into clinical studies in breast
      cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant
      lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Malignant breast cancer detection
time frame: Pre-treatment
description: A feasibility study to assess the capacity of 18F-FBnTP PEM to detect and localize malignant breast lesions. Histopathology results will serve as reference standard.
measure: Imaging comparison
time frame: Pre-treatment
description: To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests such as mammogram, 18F-FDG PEM or MRI.
arm group label: Newly diagnosed breast cancer
arm group type: Experimental
description: Patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e. index cancer). Patients will undergo FBnTP PET imaging for detection of malignant breast cancer.
intervention type: Drug
intervention name: FBnTP
description: A PET imaging radiotracer
arm group label: Newly diagnosed breast cancer
other name: Fluorobenzyl triphenyl phosphonium
criteria: 
gender: Female
minimum age: 26 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Pomper, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: via manuscripts publication