<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/NCT02246634</url>
  </required_header>
  <id_info>
    <org_study_id>DOCUMAS: 17HH4153</org_study_id>
    <nct_id>NCT02246634</nct_id>
  </id_info>
  <brief_title>Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE)</brief_title>
  <acronym>SERENADE</acronym>
  <official_title>Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pelican Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI&#xD;
      positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV&#xD;
      contrast) post surgery six monthly for three years.&#xD;
&#xD;
      Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who&#xD;
      make decisions as appropriate, including the management of any identified liver metastases,&#xD;
      according to local protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A phase II multicentre, interventional study to determine if additional staging at diagnosis&#xD;
      with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with&#xD;
      high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be&#xD;
      discussed at MDT and treated according to local policy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2026</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>Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.</measure>
    <time_frame>5 years after last recruit (end of trial)</time_frame>
    <description>Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.</measure>
    <time_frame>5 years after last recruit (end of trial)</time_frame>
    <description>% of patients diagnosed with liver metastases according to known prognostic risk factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.</measure>
    <time_frame>5 years after last recruit (end of trial)</time_frame>
    <description>% lesions suspected as metastatic on DW MRI confirmed by subsequent 'gold standard' of contrast enhanced MRI and/or surgical resection, and/or progressive enlargement of the lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.</measure>
    <time_frame>6mth, 12mth, 18mth, 2yr, 3yr</time_frame>
    <description>Survival and recurrence outcomes according to presence or absence of liver metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.</measure>
    <time_frame>5 years after last recruit (end of trial)</time_frame>
    <description>Fong score of all patients with liver metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.</measure>
    <time_frame>5 years after last recruit (end of trial)</time_frame>
    <description>Proportion of patients undergoing curative treatment and methods of treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">282</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Neoplasm Metastases</condition>
  <condition>Hepatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Diffusion Weighted MRI scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diffusion Weighted MRI scan</intervention_name>
    <description>Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.</description>
    <arm_group_label>Diffusion Weighted MRI scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a high risk primary colorectal malignancy&#xD;
&#xD;
          2. Have a negative CT or includes no confirmatory evidence of liver metastases&#xD;
&#xD;
          3. Is able to undergo treatment if liver metastasis is found&#xD;
&#xD;
          4. Have provided written informed consent to participate in the study&#xD;
&#xD;
          5. Be aged 16 years or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have had a previous colorectal malignancy&#xD;
&#xD;
          2. Have metastatic disease&#xD;
&#xD;
          3. Have a synchronous second malignancy&#xD;
&#xD;
          4. Are contraindicated for MRI&#xD;
&#xD;
          5. Has a T3b or below low rectal tumour without EMVI or N1c&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gina Brown</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caroline Martin</last_name>
    <phone>+44 (0) 7749 655 817</phone>
    <email>c.martin1@imperial.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Syvella Ellis</last_name>
    <phone>+44 (0) 7732 315 234</phone>
    <email>giclinicaltrials@imperial.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Macclesfield District General Hospital</name>
      <address>
        <city>Macclesfield</city>
        <state>Cheshire</state>
        <zip>SK10 3BL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pippa Hill</last_name>
      <email>philippahill@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Lesley Wilkinson</last_name>
      <email>lesley.wilkinson8@nhs.net</email>
    </contact_backup>
    <investigator>
      <last_name>Chris Smart</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen's Hospital</name>
      <address>
        <city>Burton upon Trent</city>
        <state>Derbyshire</state>
        <zip>DE13 0RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Helena Cox</last_name>
      <email>Helena.Cox@burtonft.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Manjusha Keni</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Broomfield Hospital</name>
      <address>
        <city>Chelmsford</city>
        <state>Essex</state>
        <zip>CM1 7ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Shillito</last_name>
      <email>lauren.shillito@meht.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Peng Lee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Bolton Hospital</name>
      <address>
        <city>Bolton</city>
        <state>Greater Manchester</state>
        <zip>BL4 0JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raksha Mistry</last_name>
      <email>Raksha.mistry@boltonft.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Gemma Faulkner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medway Maritime Hospital</name>
      <address>
        <city>Gillingham</city>
        <state>Kent</state>
        <zip>ME7 5NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzie Rayner</last_name>
      <email>Suzie.Reyner@medway.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Iheoma Amaechi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of South Manchester &amp; Manchester Royal Infirmary</name>
      <address>
        <city>Wythenshawe</city>
        <state>Manchester</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsay Piper</last_name>
      <email>Lindsay.Piper@UHSM.NHS.UK</email>
    </contact>
    <investigator>
      <last_name>Sarah Duff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Noonan</last_name>
      <email>Matthew.Noonan@rlbuht.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Catriona Farrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Storer</last_name>
      <phone>01782 672557</phone>
      <email>Julie.storer@uhnm.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Michelle Swann</last_name>
      <phone>01782 675859</phone>
      <email>Michelle.Swann@uhnm.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Ravivarma Balasubramaniam</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cordelia Grant</last_name>
      <email>cordelia.grant@rmh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Christos Kontovounisios</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Gwent Hospital</name>
      <address>
        <city>Newport</city>
        <state>Wales</state>
        <zip>NP20 2UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heeam Nassa</last_name>
      <email>Heeam.Nassa@wales.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Mark Robinson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>George Eliot Hospital</name>
      <address>
        <city>Nuneaton</city>
        <state>Warwickshire</state>
        <zip>CV10 7DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pritpal Klear</last_name>
      <email>Pritpal.Klear@geh.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Holly Lawrence</last_name>
      <email>Holly.Lawrence@geh.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Jamal Abdulkarim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Salisbury District Hospital</name>
      <address>
        <city>Salisbury</city>
        <state>Wiltshire</state>
        <zip>SP2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Casey</last_name>
      <email>Ruth.Casey@salisbury.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Graham Branagan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Gibbons</last_name>
      <email>nicola.gibbons@porthosp.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Antony Higginson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Neoplasm Metastases</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Diffusion Weighted MRI</keyword>
  <keyword>Hepatic Neoplasms</keyword>
  <keyword>Tumors</keyword>
  <keyword>Neoplasms, Rectal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_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/NCT02246634
org study id: DOCUMAS: 17HH4153
nct id: NCT02246634
lead sponsor: 
collaborator: 
has dmc: Yes
Eligible patients with high risk colorectal malignancy (T3/4, spread greater than 5mm, EMVI
      positive) will have additional surveillance of breath hold T1, T2 and DW-MRIs (no IV
      contrast) post surgery six monthly for three years.

      Findings of liver MRIs as reported by radiology PI will be shared with their local MDT who
      make decisions as appropriate, including the management of any identified liver metastases,
      according to local protocol.
A phase II multicentre, interventional study to determine if additional staging at diagnosis
      with liver DW-MRI will diagnose more synchronous metastases than CT alone in patients with
      high risk colorectal cancer. Liver metastases found on the additional DW-MRI scans will be
      discussed at MDT and treated according to local policy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
time frame: 5 years after last recruit (end of trial)
description: Proportion of additional patients diagnosed with liver metastases on DW MRI compared with CT.
measure: To compare the baseline risk factors of the primary tumour against the timing and pattern of metastatic disease relapse in the liver.
time frame: 5 years after last recruit (end of trial)
description: % of patients diagnosed with liver metastases according to known prognostic risk factors
measure: To determine the sensitivity and specificity of DW-MRI as a screening method for liver lesions in patients with high risk colorectal cancer.
time frame: 5 years after last recruit (end of trial)
description: % lesions suspected as metastatic on DW MRI confirmed by subsequent 'gold standard' of contrast enhanced MRI and/or surgical resection, and/or progressive enlargement of the lesion.
measure: To describe the cancer specific disease free survival and overall survival outcomes in patients with and without liver metastases.
time frame: 6mth, 12mth, 18mth, 2yr, 3yr
description: Survival and recurrence outcomes according to presence or absence of liver metastases
measure: To characterise the patients diagnosed through screening with liver metastasis in the SERENADE study using the Fong criteria.
time frame: 5 years after last recruit (end of trial)
description: Fong score of all patients with liver metastases
measure: To describe the impact of MR screening on treatment received by patients who are diagnosed with liver metastases.
time frame: 5 years after last recruit (end of trial)
description: Proportion of patients undergoing curative treatment and methods of treatment
arm group label: Diffusion Weighted MRI scan
arm group type: Experimental
description: Patients who are enrolled in the study will undergo an additional diffusion weighted MRI (T2W, DWI and ADC sequences) of the liver.
intervention type: Other
intervention name: Diffusion Weighted MRI scan
description: Liver metastases found on the additional DW-MRI scans will be discussed at MDT and treated according to local site policy.
arm group label: Diffusion Weighted MRI scan
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Gina Brown
role: Principal Investigator
affiliation: Imperial College London
last name: Caroline Martin
phone: +44 (0) 7749 655 817
email: c.martin1@imperial.ac.uk
last name: Syvella Ellis
phone: +44 (0) 7732 315 234
email: giclinicaltrials@imperial.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms