<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/NCT03238170</url>
  </required_header>
  <id_info>
    <org_study_id>215681</org_study_id>
    <nct_id>NCT03238170</nct_id>
  </id_info>
  <brief_title>MR-simulation in Radiotherapy for Prostate Cancer</brief_title>
  <acronym>FIMRA-P</acronym>
  <official_title>An Exploratory Study to Assess the Feasibility of Incorporating MR in the Radiotherapy Pathway of Patients With Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
      To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as&#xD;
      part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy&#xD;
      planning systems, so that it can be potentially used to reduce healthy tissue exposure to&#xD;
      radiation. Subsequently, the protocols and procedures established can be used to put the&#xD;
      technique into routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide&#xD;
      an accurate 3-D picture of the local anatomy. This helps the planners to maximise the&#xD;
      radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal&#xD;
      tissue. Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging&#xD;
      technique that provides even clearer images of the local anatomy. However, until recently the&#xD;
      technology hasn't existed to allow us to perform MRI scans with patients &quot;set-up&quot; in the&#xD;
      position required to plan and deliver radiotherapy to the prostate. This study is being&#xD;
      performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy&#xD;
      planning process, which may further increase the accuracy of the treatment, reducing the&#xD;
      irradiation of surrounding normal tissue and minimising toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Operating Procedure (SOP) for MRI-simulation for prostate patients</measure>
    <time_frame>6 months</time_frame>
    <description>Write a Standard Operating Procedure (SOP) for MRI-scanning of prostate patients in the radiotherapy treatment position so that their data can be used in the treatment planning for either in-direct or MRI-only planning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Protocol for in-direct MRI planning for prostate</measure>
    <time_frame>6 months</time_frame>
    <description>Write a clinical protocol for &quot;in-direct&quot; MRI planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and these are translated onto the co-registered CT scan for treatment planning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Protocol for direct MRI-only planning for prostate</measure>
    <time_frame>18 months</time_frame>
    <description>Write a clinical protocol for &quot;direct&quot; MRI-only planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and also for dose calculation and setup verification</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cancer of the PROSTATE</condition>
  <arm_group>
    <arm_group_label>MR-Simulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have 1 MRI scan appointment, using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan. The MR scan will be performed in the radiotherapy treatment position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <description>MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan</description>
    <arm_group_label>MR-Simulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written, voluntary, informed consent&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  ECOG Performance Status ≤ 2&#xD;
&#xD;
          -  Life expectancy &gt; 12 months&#xD;
&#xD;
          -  Histologically proven carcinoma of the prostate&#xD;
&#xD;
          -  Radical radiotherapy +/- hormones indicated as the primary treatment modality&#xD;
&#xD;
          -  Staging diagnostic MRI of the prostate need to be available for comparison.&#xD;
&#xD;
          -  Adequate organ function and absence of other major concurrent illness, allowing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Impaired renal function (serum creatinine of &gt; 200)&#xD;
&#xD;
          -  Severely impaired liver function&#xD;
&#xD;
          -  Patients with allergies or contra-indications to the gadolinium contrast agent that&#xD;
             may be used in the study&#xD;
&#xD;
          -  Severe claustrophobia or inability to tolerate MRI scans&#xD;
&#xD;
          -  General contra-indications to MRI including cardiac pacemakers and defibrillators,&#xD;
             metallic prosthetic devices, aneurysm clips and metal fragments in the eyes, as&#xD;
             defined in MRI safety departmental protocols&#xD;
&#xD;
          -  Serious inter-current conditions or other non-malignant illnesses that are&#xD;
             uncontrolled or whose control may be affected by participation in this study&#xD;
&#xD;
          -  Any patient who has urinary or faecal incontinence&#xD;
&#xD;
          -  Status greater than or equal to 3&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Hughes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guy's and St. Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE19RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>March 7, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 3, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03238170
org study id: 215681
nct id: NCT03238170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the feasibility of acquiring an MR scan in the radiotherapy treatment position as
      part of the patient's radiotherapy pathway and incorporating the data into our radiotherapy
      planning systems, so that it can be potentially used to reduce healthy tissue exposure to
      radiation. Subsequently, the protocols and procedures established can be used to put the
      technique into routine clinical practice.
Conventional radiotherapy treatment planning uses computed tomography (CT) scans to provide
      an accurate 3-D picture of the local anatomy. This helps the planners to maximise the
      radiation dose delivered to the prostate, whilst minimising the dose to surrounding normal
      tissue. Magnetic resonance imaging (MRI) scanning is an established diagnostic imaging
      technique that provides even clearer images of the local anatomy. However, until recently the
      technology hasn't existed to allow us to perform MRI scans with patients "set-up" in the
      position required to plan and deliver radiotherapy to the prostate. This study is being
      performed to assess methods that may allow us to incorporate MRI scans into the radiotherapy
      planning process, which may further increase the accuracy of the treatment, reducing the
      irradiation of surrounding normal tissue and minimising toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Standard Operating Procedure (SOP) for MRI-simulation for prostate patients
time frame: 6 months
description: Write a Standard Operating Procedure (SOP) for MRI-scanning of prostate patients in the radiotherapy treatment position so that their data can be used in the treatment planning for either in-direct or MRI-only planning
measure: Clinical Protocol for in-direct MRI planning for prostate
time frame: 6 months
description: Write a clinical protocol for "in-direct" MRI planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and these are translated onto the co-registered CT scan for treatment planning
measure: Clinical Protocol for direct MRI-only planning for prostate
time frame: 18 months
description: Write a clinical protocol for "direct" MRI-only planning of prostate external beam radiotherapy, whereby MRI data is used to define anatomical structures and also for dose calculation and setup verification
arm group label: MR-Simulation
arm group type: Experimental
description: Patients will have 1 MRI scan appointment, using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan. The MR scan will be performed in the radiotherapy treatment position.
intervention type: Device
intervention name: MRI scan
description: MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan
arm group label: MR-Simulation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Hughes
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
submitted: April 3, 2023