<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/NCT03293602</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2014/26</org_study_id>
    <nct_id>NCT03293602</nct_id>
  </id_info>
  <brief_title>MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging</brief_title>
  <acronym>MISOBOLD</acronym>
  <official_title>MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancéropôle GSO and GIRCI SOOM (API-K)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      This feasibility exploratory study objective is to assess the ability of combined MRI BOLD&#xD;
      and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained&#xD;
      after radical prostatectomy in order to, in time, be able to identify patient with bad&#xD;
      prognostic and to offer them the best therapeutic strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty&#xD;
      thousand curative treatments are performed each year, but 25 to 30% of these patients will&#xD;
      present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu&#xD;
      hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular&#xD;
      damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA&#xD;
      healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance.&#xD;
      L. Marignol &amp;al clearly showed that hypoxia may have a main role in hormonal resistance.&#xD;
      Furthermore, M. Milosevic &amp; al showed that hypoxia is an independent factor of local&#xD;
      reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could&#xD;
      be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible&#xD;
      to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a&#xD;
      18F-misonidazole PET before surgery. The results of these two technics will be compared to&#xD;
      the histological results using CAIX and HIF immunohistochemistery markers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    the team has changed. the new team did not have the perosnnel to set up the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>comparison between histological results and oxygenation quantitative values from MRI and PET exams</measure>
    <time_frame>Inclusion, 1 month</time_frame>
    <description>Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and:&#xD;
on one hand PET FMISO uptake&#xD;
on the other hand, MRI BOLD signal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quantitative analysis</measure>
    <time_frame>Inclusion, 1 month</time_frame>
    <description>a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>F-MISO PET imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>F-MISO PET imaging</intervention_name>
    <description>F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.</description>
    <arm_group_label>F-MISO PET imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient above 18.&#xD;
&#xD;
          -  Prostate tumor with histological confirmed diagnosis and highly radiological suspected&#xD;
             target on MRI&#xD;
&#xD;
          -  High risk patient : &gt;T2c grade, Glasgow score &gt; 7 and PSA &gt; 20ng/ml&#xD;
&#xD;
          -  Surgical treatment chosen during multidisciplinary meeting&#xD;
&#xD;
          -  ECOG ≤2&#xD;
&#xD;
          -  Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery&#xD;
&#xD;
          -  Member or beneficiary of a social security system.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient included in another clinical study&#xD;
&#xD;
          -  Geographical, social or psychological reasons preventing patient from submitting to&#xD;
             the study's medical monitoring&#xD;
&#xD;
          -  Patient deprive of liberty, adult subjects to legal protection or unable to give&#xD;
             consent&#xD;
&#xD;
          -  Contraindications to MRI&#xD;
&#xD;
          -  Contraindication to gadolinium injection&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre de Lutte Contre le Cancer</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>MRI</keyword>
  <keyword>BOLD</keyword>
  <keyword>18F-MISO</keyword>
  <keyword>PET</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Hypoxia</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/NCT03293602
org study id: CHUBX 2014/26
nct id: NCT03293602
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This feasibility exploratory study objective is to assess the ability of combined MRI BOLD
      and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained
      after radical prostatectomy in order to, in time, be able to identify patient with bad
      prognostic and to offer them the best therapeutic strategy.
Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty
      thousand curative treatments are performed each year, but 25 to 30% of these patients will
      present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu
      hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular
      damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA
      healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance.
      L. Marignol &al clearly showed that hypoxia may have a main role in hormonal resistance.
      Furthermore, M. Milosevic & al showed that hypoxia is an independent factor of local
      reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could
      be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible
      to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a
      18F-misonidazole PET before surgery. The results of these two technics will be compared to
      the histological results using CAIX and HIF immunohistochemistery markers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: comparison between histological results and oxygenation quantitative values from MRI and PET exams
time frame: Inclusion, 1 month
description: Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and:
on one hand PET FMISO uptake
on the other hand, MRI BOLD signal
measure: quantitative analysis
time frame: Inclusion, 1 month
description: a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities
arm group label: F-MISO PET imaging
arm group type: Experimental
description: F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
intervention type: Device
intervention name: F-MISO PET imaging
description: F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
arm group label: F-MISO PET imaging
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Hypoxia
sharing ipd: No