<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/NCT01665703</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1213</org_study_id>
    <nct_id>NCT01665703</nct_id>
  </id_info>
  <brief_title>Imaging Correlates of Renal Cell Carcinoma Biological Features</brief_title>
  <official_title>LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is designed to evaluate imaging parameters indicative of underlying tumor&#xD;
      biology. Patients with large renal masses (&gt;3 cm, or at the discretion of the investigator)&#xD;
      who are planning to undergo nephrectomy will be identified, and recruited to undergo a&#xD;
      contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography&#xD;
      (MR-FDG-PET) scan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is designed to evaluate imaging parameters indicative of underlying tumor&#xD;
      biology. Patients with large renal masses (&gt;3 cm, or at the discretion of the investigator)&#xD;
      who are planning to undergo nephrectomy will be identified, and recruited to undergo a&#xD;
      contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography&#xD;
      (MR-FDG-PET) scan. Samples collected from their tumor after it is removed will undergo a&#xD;
      variety of laboratory tests, including biomarker assessments and genotyping. By examining&#xD;
      primary renal masses via a combination of MR and FDG-PET functional imaging in concert with&#xD;
      tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as&#xD;
      features of HIF activation or tumor subtype.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features</measure>
    <time_frame>4 weeks</time_frame>
    <description>This is a feasibility study. Feasibility will be determined by the quality of the FDG-PET-MRI measurements. That is, the measurements represent what the investigators hope they are measuring. With 10 of 10, the 100% rate has an exact 95% confidence interval of 69% to 100%. The interval width, representing a measure of precision, is 31%. The tumor biological features that will be assessed include genetic analyses performed for commonly mutated genes in kidney cancer (VHL, PBRM1, SETD2, HIF1, UTX, MLL2) and protein expression analyses performed on HIF1 and HIF2 protein expression using standard immunohistochemistry. These genetic and protein expression analyses will be performed on tissue samples collected within four weeks of imaging from tissue removed via nephrectomy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>FDG PET/MR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participents will undergo a gadolinium enhanced FDG PET/MR study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FDG PET/MR</intervention_name>
    <description>Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.</description>
    <arm_group_label>FDG PET/MR</arm_group_label>
    <other_name>Fluorodeoxyglucose Positron Emission Tomography MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age (no upper age limit)&#xD;
&#xD;
          -  Informed consent obtained and signed&#xD;
&#xD;
          -  Clinically suspected RCC based on imaging performed prior to enrollment&#xD;
&#xD;
          -  Planned nephrectomy schedule that can accommodate a MR-FDG-PET scan within 4 weeks&#xD;
             prior to surgery&#xD;
&#xD;
          -  Willing to undergo gadolinium enhanced MRI with simultaneous acquisition of FDG-PET&#xD;
             uptake by the tumor within 4 weeks prior to nephrectomy&#xD;
&#xD;
          -  Willing to consent for genetic and proteomic analysis of tumor and germline nucleic&#xD;
             acids&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum or urine pregnancy test&#xD;
             performed within 7 days prior to FDG-PET-MRI&#xD;
&#xD;
          -  Breast feeding women cannot do so for 24 hours after FDG injection&#xD;
&#xD;
          -  Patient is willing to fast for 4 hours, including avoiding any sugar-containing&#xD;
             drinks.&#xD;
&#xD;
          -  Patient is willing to drink at least 32 ounces of water (or other no-sugar-containing&#xD;
             fluids) within 4 hours prior to arriving for scans.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe reaction to gadolinium-enhanced MRI&#xD;
&#xD;
          -  Poorly controlled diabetes mellitus&#xD;
&#xD;
          -  Inability to tolerate PET and/or MRI&#xD;
&#xD;
          -  Presence of pacemaker or intracranial aneurysm clip&#xD;
&#xD;
          -  GFR &lt; 30mL/min as measured via Cockcroft-Gault equation&#xD;
&#xD;
          -  Inability to lie flat for &gt;1 hour&#xD;
&#xD;
          -  Pregnant female&#xD;
&#xD;
          -  History of a prior malignancy within past 5 years are excluded unless they have been&#xD;
             disease free for 3 or more years or unless they have a completely resected&#xD;
             non-melanoma skin cancer, low risk prostate cancer, or other low risk tumor history at&#xD;
             the discretion of the investigator.&#xD;
&#xD;
          -  Substance abuse, medical, psychological, or social conditions that may interfere with&#xD;
             the patient's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weili Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://unclineberger.org/</url>
    <description>Lineberger Comprehensive Cancer Center website</description>
  </link>
  <link>
    <url>http://www.cancer.gov/</url>
    <description>National Cancer Institute (NCI) website</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>[18F]</keyword>
  <keyword>Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging</keyword>
  <keyword>FDG-PET-MRI</keyword>
  <keyword>Renal Cell Carcinoma</keyword>
  <keyword>Pilot Study</keyword>
  <keyword>LCCC 1213</keyword>
  <keyword>UNC Lineberger</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01665703
org study id: LCCC1213
nct id: NCT01665703
lead sponsor: 
has dmc: Yes
This pilot study is designed to evaluate imaging parameters indicative of underlying tumor
      biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)
      who are planning to undergo nephrectomy will be identified, and recruited to undergo a
      contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography
      (MR-FDG-PET) scan.
This pilot study is designed to evaluate imaging parameters indicative of underlying tumor
      biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)
      who are planning to undergo nephrectomy will be identified, and recruited to undergo a
      contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography
      (MR-FDG-PET) scan. Samples collected from their tumor after it is removed will undergo a
      variety of laboratory tests, including biomarker assessments and genotyping. By examining
      primary renal masses via a combination of MR and FDG-PET functional imaging in concert with
      tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as
      features of HIF activation or tumor subtype.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
time frame: 4 weeks
description: This is a feasibility study. Feasibility will be determined by the quality of the FDG-PET-MRI measurements. That is, the measurements represent what the investigators hope they are measuring. With 10 of 10, the 100% rate has an exact 95% confidence interval of 69% to 100%. The interval width, representing a measure of precision, is 31%. The tumor biological features that will be assessed include genetic analyses performed for commonly mutated genes in kidney cancer (VHL, PBRM1, SETD2, HIF1, UTX, MLL2) and protein expression analyses performed on HIF1 and HIF2 protein expression using standard immunohistochemistry. These genetic and protein expression analyses will be performed on tissue samples collected within four weeks of imaging from tissue removed via nephrectomy.
arm group label: FDG PET/MR
arm group type: Experimental
description: Participents will undergo a gadolinium enhanced FDG PET/MR study.
intervention type: Procedure
intervention name: FDG PET/MR
description: Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.
arm group label: FDG PET/MR
other name: Fluorodeoxyglucose Positron Emission Tomography MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Weili Lin, PhD
role: Principal Investigator
affiliation: University of North Carolina
facility: 
country: United States
url: http://unclineberger.org/
description: Lineberger Comprehensive Cancer Center website
url: http://www.cancer.gov/
description: National Cancer Institute (NCI) website
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Fluorodeoxyglucose F18