<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/NCT02966574</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-IRM CE</org_study_id>
    <nct_id>NCT02966574</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging of the Whole Body, Including Diffusion, in the Medical Evaluation of Breast Cancers at High Risk for Metastasis and the Follow-up of Metastatic Cancers</brief_title>
  <official_title>Magnetic Resonance Imaging of the Whole Body, Including Diffusion, in the Medical Evaluation of Breast Cancers at High Risk for Metastasis and the Follow-up of Metastatic Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated&#xD;
      its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are&#xD;
      very osteophilic and bones are the most frequent metastatic site.&#xD;
&#xD;
      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides&#xD;
      quantitative functional criteria (diffusion and ADC values). According to a recent study,&#xD;
      whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the&#xD;
      diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.&#xD;
&#xD;
      Therefore, it seems appropriate to study the performance of whole body MRI in the&#xD;
      pre-therapeutic assessment of breast cancer with a high risk for metastasis and the&#xD;
      monitoring of metastatic breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated&#xD;
      its interest in metastatic cancers.&#xD;
&#xD;
      Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the&#xD;
      most frequent metastatic site. Other sites include the lungs, liver, pleura, distant lymph&#xD;
      nodes, soft tissue and the central nervous system.&#xD;
&#xD;
      Metastasis are located exclusively in the bones in 30% of the cases. The most commonly&#xD;
      affected bones include the axial skeleton, rich in hematopoietic bone marrow : column,&#xD;
      pelvis, skull, ribs, clavicles, the proximal part of the femur and humerus. Five percent of&#xD;
      breast cancers are directly metastatic and 20 to 30% of localized breast cancers progress to&#xD;
      metastatic stage. This potentially affects a large number of patients, with a median survival&#xD;
      of 30 to 36 months.Patients with bone metastases only have a better survival rate than&#xD;
      others: 20% at 5 years. It is therefore important to use a reliable and reproducible&#xD;
      examination for the monitoring of treatment response.&#xD;
&#xD;
      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides&#xD;
      quantitative functional criteria (diffusion and ADC values). According to a recent study,&#xD;
      whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the&#xD;
      diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.&#xD;
      However, this is a preliminary study with a limited and heterogeneous cohort of patients.&#xD;
&#xD;
      Therefore, it seems appropriate to study the performance of whole body MRI in the&#xD;
      pre-therapeutic assessment of breast cancer with a high risk for metastasis and the&#xD;
      monitoring of metastatic breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 13, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Apparent diffusion coefficient (ADC) (mm2/sec)</measure>
    <time_frame>Once per year for a maximum of 2 years</time_frame>
    <description>Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cancer lesions</measure>
    <time_frame>Once per year for a maximum of 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Exact localisation of cancer lesions</measure>
    <time_frame>Once per year for a maximum of 2 years</time_frame>
    <description>Systematic lecture grid. Possible choices are:&#xD;
Nodes (Axillary, internal mammary, supra and infraclavicular, cervical, mediastinal, hilar, upper abdomen, pelvic, inguinal), Bone (Spine, Scapular Belt, Costal Grill, Pelvic Belt)- Lungs and pleura - Liver (and other viscera)- Soft tissues and skin- Brain and spinal cord- Other</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Metastatic Breastcancer</condition>
  <arm_group>
    <arm_group_label>metastatic breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>whole body MRI</intervention_name>
    <description>The examination will be conducted in the pretreatment assessment of breast cancers with a high metastasis risk and in the monitoring of metastatic breast cancers. The examination is performed without intravenous injection of contrast medium, from the top of the skull to mid-thigh using diffusion weighted sequences in the axial plane, T1-weighted sequences in the coronal plane, STIR T2 weighted sequences in the coronal plane and T1-weighted sequences in the sagittal plane on the spine. Total examination duration is one hour. The interpretation of the results is made by two independent reporters with a complementary expertise, according to a systematic lecture grid.</description>
    <arm_group_label>metastatic breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of breast carcinoma B5&#xD;
&#xD;
          -  Axillary lymph node punction C5 or metastatic&#xD;
&#xD;
          -  Performance status from 0 to 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ferromagnetic metallic foreign bodies (pacemakers, implanted cochlear,&#xD;
             neurostimulator, ...)&#xD;
&#xD;
          -  Claustrophobia&#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>Nathalie Hottat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathalie Hottat, MD</last_name>
    <phone>32 2 4754187</phone>
    <email>Nathalie.HOTTAT@chu-brugmann.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathalie Hottat, MD</last_name>
      <email>Nathalie.HOTTAT@chu-brugmann.be</email>
    </contact>
    <investigator>
      <last_name>Nathalie Hottat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mieke Cannie, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Bidard FC, Vincent-Salomon A, Gomme S, Nos C, de Rycke Y, Thiery JP, Sigal-Zafrani B, Mignot L, Sastre-Garau X, Pierga JY; Institut Curie Breast Cancer Study Group. Disseminated tumor cells of breast cancer patients: a strong prognostic factor for distant and local relapse. Clin Cancer Res. 2008 Jun 1;14(11):3306-11. doi: 10.1158/1078-0432.CCR-07-4749.</citation>
    <PMID>18519757</PMID>
  </reference>
  <reference>
    <citation>Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298. No abstract available.</citation>
    <PMID>26314782</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Dimopoulos MA, Hillengass J, Usmani S, Zamagni E, Lentzsch S, Davies FE, Raje N, Sezer O, Zweegman S, Shah J, Badros A, Shimizu K, Moreau P, Chim CS, Lahuerta JJ, Hou J, Jurczyszyn A, Goldschmidt H, Sonneveld P, Palumbo A, Ludwig H, Cavo M, Barlogie B, Anderson K, Roodman GD, Rajkumar SV, Durie BG, Terpos E. Role of magnetic resonance imaging in the management of patients with multiple myeloma: a consensus statement. J Clin Oncol. 2015 Feb 20;33(6):657-64. doi: 10.1200/JCO.2014.57.9961. Epub 2015 Jan 20.</citation>
    <PMID>25605835</PMID>
  </reference>
  <reference>
    <citation>Woolf DK, Padhani AR, Makris A. Assessing response to treatment of bone metastases from breast cancer: what should be the standard of care? Ann Oncol. 2015 Jun;26(6):1048-1057. doi: 10.1093/annonc/mdu558. Epub 2014 Dec 3.</citation>
    <PMID>25471332</PMID>
  </reference>
  <reference>
    <citation>Jambor I, Kuisma A, Ramadan S, Huovinen R, Sandell M, Kajander S, Kemppainen J, Kauppila E, Auren J, Merisaari H, Saunavaara J, Noponen T, Minn H, Aronen HJ, Seppanen M. Prospective evaluation of planar bone scintigraphy, SPECT, SPECT/CT, 18F-NaF PET/CT and whole body 1.5T MRI, including DWI, for the detection of bone metastases in high risk breast and prostate cancer patients: SKELETA clinical trial. Acta Oncol. 2016;55(1):59-67. doi: 10.3109/0284186X.2015.1027411. Epub 2015 Apr 2.</citation>
    <PMID>25833330</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Mieke Cannie</investigator_full_name>
    <investigator_title>Head of clinic</investigator_title>
  </responsible_party>
  <keyword>Whole body MRI</keyword>
  <keyword>Breastcancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Breast Neoplasms</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/NCT02966574
org study id: CHUB-IRM CE
nct id: NCT02966574
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated
      its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are
      very osteophilic and bones are the most frequent metastatic site.

      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides
      quantitative functional criteria (diffusion and ADC values). According to a recent study,
      whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the
      diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.

      Therefore, it seems appropriate to study the performance of whole body MRI in the
      pre-therapeutic assessment of breast cancer with a high risk for metastasis and the
      monitoring of metastatic breast cancer.
Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated
      its interest in metastatic cancers.

      Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the
      most frequent metastatic site. Other sites include the lungs, liver, pleura, distant lymph
      nodes, soft tissue and the central nervous system.

      Metastasis are located exclusively in the bones in 30% of the cases. The most commonly
      affected bones include the axial skeleton, rich in hematopoietic bone marrow : column,
      pelvis, skull, ribs, clavicles, the proximal part of the femur and humerus. Five percent of
      breast cancers are directly metastatic and 20 to 30% of localized breast cancers progress to
      metastatic stage. This potentially affects a large number of patients, with a median survival
      of 30 to 36 months.Patients with bone metastases only have a better survival rate than
      others: 20% at 5 years. It is therefore important to use a reliable and reproducible
      examination for the monitoring of treatment response.

      Apart from morphological criteria (lesion size and RECIST criteria), MRI provides
      quantitative functional criteria (diffusion and ADC values). According to a recent study,
      whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the
      diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.
      However, this is a preliminary study with a limited and heterogeneous cohort of patients.

      Therefore, it seems appropriate to study the performance of whole body MRI in the
      pre-therapeutic assessment of breast cancer with a high risk for metastasis and the
      monitoring of metastatic breast cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Apparent diffusion coefficient (ADC) (mm2/sec)
time frame: Once per year for a maximum of 2 years
description: Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
measure: Number of cancer lesions
time frame: Once per year for a maximum of 2 years
measure: Exact localisation of cancer lesions
time frame: Once per year for a maximum of 2 years
description: Systematic lecture grid. Possible choices are:
Nodes (Axillary, internal mammary, supra and infraclavicular, cervical, mediastinal, hilar, upper abdomen, pelvic, inguinal), Bone (Spine, Scapular Belt, Costal Grill, Pelvic Belt)- Lungs and pleura - Liver (and other viscera)- Soft tissues and skin- Brain and spinal cord- Other
arm group label: metastatic breast cancer
arm group type: Experimental
intervention type: Device
intervention name: whole body MRI
description: The examination will be conducted in the pretreatment assessment of breast cancers with a high metastasis risk and in the monitoring of metastatic breast cancers. The examination is performed without intravenous injection of contrast medium, from the top of the skull to mid-thigh using diffusion weighted sequences in the axial plane, T1-weighted sequences in the coronal plane, STIR T2 weighted sequences in the coronal plane and T1-weighted sequences in the sagittal plane on the spine. Total examination duration is one hour. The interpretation of the results is made by two independent reporters with a complementary expertise, according to a systematic lecture grid.
arm group label: metastatic breast cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathalie Hottat, MD
role: Principal Investigator
affiliation: CHU Brugmann
last name: Nathalie Hottat, MD
phone: 32 2 4754187
email: Nathalie.HOTTAT@chu-brugmann.be
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Belgium
citation: Bidard FC, Vincent-Salomon A, Gomme S, Nos C, de Rycke Y, Thiery JP, Sigal-Zafrani B, Mignot L, Sastre-Garau X, Pierga JY; Institut Curie Breast Cancer Study Group. Disseminated tumor cells of breast cancer patients: a strong prognostic factor for distant and local relapse. Clin Cancer Res. 2008 Jun 1;14(11):3306-11. doi: 10.1158/1078-0432.CCR-07-4749.
PMID: 18519757
citation: Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298. No abstract available.
PMID: 26314782
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
citation: Dimopoulos MA, Hillengass J, Usmani S, Zamagni E, Lentzsch S, Davies FE, Raje N, Sezer O, Zweegman S, Shah J, Badros A, Shimizu K, Moreau P, Chim CS, Lahuerta JJ, Hou J, Jurczyszyn A, Goldschmidt H, Sonneveld P, Palumbo A, Ludwig H, Cavo M, Barlogie B, Anderson K, Roodman GD, Rajkumar SV, Durie BG, Terpos E. Role of magnetic resonance imaging in the management of patients with multiple myeloma: a consensus statement. J Clin Oncol. 2015 Feb 20;33(6):657-64. doi: 10.1200/JCO.2014.57.9961. Epub 2015 Jan 20.
PMID: 25605835
citation: Woolf DK, Padhani AR, Makris A. Assessing response to treatment of bone metastases from breast cancer: what should be the standard of care? Ann Oncol. 2015 Jun;26(6):1048-1057. doi: 10.1093/annonc/mdu558. Epub 2014 Dec 3.
PMID: 25471332
citation: Jambor I, Kuisma A, Ramadan S, Huovinen R, Sandell M, Kajander S, Kemppainen J, Kauppila E, Auren J, Merisaari H, Saunavaara J, Noponen T, Minn H, Aronen HJ, Seppanen M. Prospective evaluation of planar bone scintigraphy, SPECT, SPECT/CT, 18F-NaF PET/CT and whole body 1.5T MRI, including DWI, for the detection of bone metastases in high risk breast and prostate cancer patients: SKELETA clinical trial. Acta Oncol. 2016;55(1):59-67. doi: 10.3109/0284186X.2015.1027411. Epub 2015 Apr 2.
PMID: 25833330
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Mieke Cannie
investigator title: Head of clinic
mesh term: Neoplasm Metastasis
mesh term: Breast Neoplasms
sharing ipd: No