<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/NCT03034070</url>
  </required_header>
  <id_info>
    <org_study_id>TFE TVE</org_study_id>
    <nct_id>NCT03034070</nct_id>
  </id_info>
  <brief_title>Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.</brief_title>
  <acronym>TFE-TVE</acronym>
  <official_title>Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer. Comparison of Diagnostic Performance of GE mDixon and FSE, for Bone and Node Staging in Patients With Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess and compare the diagnostic performances and image quality of two WB 3D&#xD;
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :&#xD;
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its&#xD;
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,&#xD;
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening&#xD;
      of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its&#xD;
      implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB&#xD;
      MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and&#xD;
      fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau&#xD;
      inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent&#xD;
      research has confirmed the feasibility of replacing the 2D anatomical sequences by a single&#xD;
      three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).&#xD;
&#xD;
      This study will assess and compare the diagnostic performances and image quality of two WB 3D&#xD;
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :&#xD;
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its&#xD;
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,&#xD;
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.&#xD;
&#xD;
      The aim of this study is to evaluate the feasibility of the replacement of the WB 3D&#xD;
      T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</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>Diagnostic performances of 3D GE T1 sub-sequences</measure>
    <time_frame>3 months</time_frame>
    <description>Sensitivity, sensibility, positive and negative Predictive Values (PV) will be calculated with the results of each reading, and compared.&#xD;
The physical parameters of the different techniques will also be compared (Signal-to-noise ratio, contrast-to-noise ratio, ...).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Metastasis</condition>
  <arm_group>
    <arm_group_label>Diagnostic performance 3D T1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A 3D T1-weighted GE mDixon MR imaging sequence will be added to the routine 3D T1-weighted FSE sequence. mDixon sub-sequences (Fat and In Phase) are compared to 3D T1-weighted FSE in terms of diagnostic accuracy for M and N staging in prostate cancer patients: Fat, In Phase, Fat+In Phase and the routine 3D T1 will be analyzed separately, blindly and randomly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic performance 3D T1</intervention_name>
    <description>Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an &quot;interventional&quot; study.</description>
    <arm_group_label>Diagnostic performance 3D T1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  prostate cancer with high risk for metastases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindications to MRI&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Lecouvet FE, El Mouedden J, Collette L, Coche E, Danse E, Jamar F, Machiels JP, Vande Berg B, Omoumi P, Tombal B. Can whole-body magnetic resonance imaging with diffusion-weighted imaging replace Tc 99m bone scanning and computed tomography for single-step detection of metastases in patients with high-risk prostate cancer? Eur Urol. 2012 Jul;62(1):68-75. doi: 10.1016/j.eururo.2012.02.020. Epub 2012 Feb 17.</citation>
    <PMID>22366187</PMID>
  </results_reference>
  <results_reference>
    <citation>Pasoglou V, Michoux N, Peeters F, Larbi A, Tombal B, Selleslagh T, Omoumi P, Vande Berg BC, Lecouvet FE. Whole-body 3D T1-weighted MR imaging in patients with prostate cancer: feasibility and evaluation in screening for metastatic disease. Radiology. 2015 Apr;275(1):155-66. doi: 10.1148/radiol.14141242. Epub 2014 Dec 15.</citation>
    <PMID>25513855</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>MRI sequences</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>staging</keyword>
  <keyword>bone metastasis</keyword>
  <keyword>node metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</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/NCT03034070
org study id: TFE TVE
nct id: NCT03034070
lead sponsor: 
has dmc: Yes
This study will assess and compare the diagnostic performances and image quality of two WB 3D
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.
Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening
      of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its
      implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB
      MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and
      fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau
      inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent
      research has confirmed the feasibility of replacing the 2D anatomical sequences by a single
      three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).

      This study will assess and compare the diagnostic performances and image quality of two WB 3D
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.

      The aim of this study is to evaluate the feasibility of the replacement of the WB 3D
      T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic performances of 3D GE T1 sub-sequences
time frame: 3 months
description: Sensitivity, sensibility, positive and negative Predictive Values (PV) will be calculated with the results of each reading, and compared.
The physical parameters of the different techniques will also be compared (Signal-to-noise ratio, contrast-to-noise ratio, ...).
arm group label: Diagnostic performance 3D T1
arm group type: Other
description: A 3D T1-weighted GE mDixon MR imaging sequence will be added to the routine 3D T1-weighted FSE sequence. mDixon sub-sequences (Fat and In Phase) are compared to 3D T1-weighted FSE in terms of diagnostic accuracy for M and N staging in prostate cancer patients: Fat, In Phase, Fat+In Phase and the routine 3D T1 will be analyzed separately, blindly and randomly.
intervention type: Diagnostic Test
intervention name: Diagnostic performance 3D T1
description: Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an "interventional" study.
arm group label: Diagnostic performance 3D T1
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Belgium
citation: Lecouvet FE, El Mouedden J, Collette L, Coche E, Danse E, Jamar F, Machiels JP, Vande Berg B, Omoumi P, Tombal B. Can whole-body magnetic resonance imaging with diffusion-weighted imaging replace Tc 99m bone scanning and computed tomography for single-step detection of metastases in patients with high-risk prostate cancer? Eur Urol. 2012 Jul;62(1):68-75. doi: 10.1016/j.eururo.2012.02.020. Epub 2012 Feb 17.
PMID: 22366187
citation: Pasoglou V, Michoux N, Peeters F, Larbi A, Tombal B, Selleslagh T, Omoumi P, Vande Berg BC, Lecouvet FE. Whole-body 3D T1-weighted MR imaging in patients with prostate cancer: feasibility and evaluation in screening for metastatic disease. Radiology. 2015 Apr;275(1):155-66. doi: 10.1148/radiol.14141242. Epub 2014 Dec 15.
PMID: 25513855
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Neoplasm Metastasis
sharing ipd: No