<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/NCT02973828</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4576</org_study_id>
    <nct_id>NCT02973828</nct_id>
  </id_info>
  <brief_title>PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy</brief_title>
  <official_title>Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Cancer Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Cancer Research, United Kingdom</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>
      In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment&#xD;
      to locate the tumour and ensure the radiation is hitting the target.&#xD;
&#xD;
      These x-rays expose patients to additional radiation and the quality of these scans is often&#xD;
      poor which makes it difficult to distinguish tumour from normal tissue and there may be&#xD;
      uncertainty in the tumour position due to movement or shrinkage. To allow for these&#xD;
      uncertainties a large margin around the tumour is also treated, but this means that large&#xD;
      volumes of normal tissue also receive significant doses of radiation, which can result in&#xD;
      early and late toxicity.&#xD;
&#xD;
      MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the&#xD;
      difference between tumour and normal tissues and does not expose patients to additional&#xD;
      radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear&#xD;
      accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the&#xD;
      Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently&#xD;
      installation a prototype, which will be one of the first in the world. This revolutionary&#xD;
      technology has the potential to change the way radiotherapy is delivered. We hope the&#xD;
      improved precision and accuracy in hitting the target will mean reductions in margins around&#xD;
      tumours and that this will lead to higher cure rates with significantly fewer side effects.&#xD;
      Studies are required to simulate treatment on the MR Linac before it can be used in routine&#xD;
      clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and&#xD;
      patients who are currently undergoing treatment. This study will involve imaging with MRI in&#xD;
      healthy volunteers as well as in patient volunteers before and during their standard course&#xD;
      of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR&#xD;
      Linac-based research focusing on clinical application and establishment into a MR-CT and MR&#xD;
      only workflow, treatment adaptation and quality assurance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study protocol for the acquisition of MR Linac derived images with a view to MRIgRT&#xD;
      for patients undergoing radiotherapy with radical intent at sites predicted to benefit most&#xD;
      from MRIgRT (namely, for rectum, cervix, lung, prostate, bladder, breast, brain, oesophagus,&#xD;
      head and neck, hepato-pancreato-biliary (HPB) and paediatric abdomino-thoracic cancers).&#xD;
      These will be used to build a database of MR images for MR Linac-based research focusing on&#xD;
      clinical application and establishment into a MR-CT and MR only workflow, treatment&#xD;
      adaptation and quality assurance. The primary aims are to 1) develop MR Linac image sequences&#xD;
      suitable for seeing tumour/target and normal tissue at the time of radiotherapy and 2)&#xD;
      determine variations in image registrations and tissue contouring using the MR Linac images.&#xD;
      Four stages of imaging development sub-studies will be included in this protocol for&#xD;
      optimisation of MR imaging on the MR Linac. Consideration will be given to image quality,&#xD;
      scan times, and IT requirements for reconstruction, storage and image transfer.&#xD;
&#xD;
      These imaging sub-studies will be:&#xD;
&#xD;
      A) Non-patient Volunteer Imaging Studies of Normal Tissue (n = 18 - 54 per centre). The four&#xD;
      anatomical regions selected to be studied are Head and neck, Thorax (chest wall/breast and&#xD;
      lung/oesophagus), Abdomen and Pelvis (male and female). Recruitment will continue until&#xD;
      imaging from a minimum of three consecutive patients using the same 'exam card' are deemed to&#xD;
      be acceptable for normal tissue visualisation for each anatomical site.&#xD;
&#xD;
      B) Patient Volunteer Imaging Studies of Normal Tissue (n = 39 - 72 per centre). We will&#xD;
      further develop the protocols to visualise site specific tumours in 13 target areas (brain,&#xD;
      oropharynx/larynx/hypopharynx, oesophagus, lung, chest wall _+/- regional lymph nodes),&#xD;
      paediatric abdomen-thoracic cancers, hepatobiliary tract, bladder, gynaecology, prostate,&#xD;
      rectum, oligomets bone and oliogmets soft tissue). Patients will be recruited for imaging for&#xD;
      a minimum of one and maximum of 12 imaging sessions whilst undergoing radiotherapy planning&#xD;
      and/or radiotherapy treatment. Repeat imaging will allow for the determination of protocol&#xD;
      robustness. The aim will be to produce images appropriate for tumour and normal tissue&#xD;
      visualisation with a view to directing radiotherapy. Recruitment will continue until imaging&#xD;
      from a minimum of three consecutive patients using the same 'exam card' are deemed to be&#xD;
      acceptable for tumour/target visualisation at each site.&#xD;
&#xD;
      C) Pathway development studies (n = 39 - 208 per centre). At each centre, it is estimated&#xD;
      that 16 imaging sessions per tumour site are required for inter and intra registration&#xD;
      observer variability. To establish library of images to be used to develop adaptive&#xD;
      radiotherapy workflows, up to 50 imaging sessions may be required depending on the tumour&#xD;
      site. Images for normal tissue and tumour visualisation will also be used to refine exam&#xD;
      cards from Stage B.&#xD;
&#xD;
      This stage requires a minimum of three patient volunteers to be recruited to each tumour site&#xD;
      which may (or may not) include images acquired in the previous Stage B of the study, and a&#xD;
      maximum of 16 patient volunteers to reach the desired number of imaging sessions. Each&#xD;
      volunteer should undergo a minimum of two and not more than twelve imaging sessions (max&#xD;
      1/day, 3/week). The methodology of image acquisition will follow methodology for Stage B as&#xD;
      above. The primary aim will be to establish that both online and offline image-matching using&#xD;
      MR Linac with a view to guiding radiotherapy treatments can be undertaken with minimal intra&#xD;
      and inter user variability. Development of treatment workflow to help implement radiotherapy&#xD;
      treatment on the MR Linac can also be carried out. Refined exam cards from Stage B but fine&#xD;
      tuning as necessary can be used to acquire sets of images and to use this information to plan&#xD;
      treatment by simulating an on-line treatment whilst not delivering radiation.&#xD;
&#xD;
      D) On-going image development and continuous quality improvement of images&#xD;
&#xD;
      This stage of the study can run in parallel, subsequent to or independently of stages B and&#xD;
      C. The purpose will be to recruit patients receiving radiotherapy, non-radiotherapy cancer&#xD;
      patients or non-patient volunteers in order to optimise MRI guided radiotherapy delivery.&#xD;
      Examples of this include, investigating suitability of radiotherapy immobilisation devices&#xD;
      for patient positioning and treatment set-up development and/or development of new/novel&#xD;
      imaging sequences, optimisation of existing sequences and undertaking continuing image&#xD;
      quality improvement for the tumour sites listed in this protocol. Adult patient with cancers&#xD;
      not conventionally treated using radiotherapy could be recruited in order to investigate&#xD;
      whether radiotherapy could be used as a treatment modality in the future. Patients with&#xD;
      unusual or rare cancer (for example sarcoma, kidney and lymphoma) that do receive&#xD;
      radiotherapy could be recruited to investigate the benefit of using the MR Linac for cancers&#xD;
      of this type.&#xD;
&#xD;
      The total number of volunteers is, as yet, unknown; however the recruitment progress will be&#xD;
      monitored by the trial management group (TMG). The TMG will ensure that this protocol is&#xD;
      being adhered to, that all volunteers are being imaged safely and that the information gained&#xD;
      from the imaging sessions is being used appropriately. The investigator may recruit between&#xD;
      one and five volunteers (patient, non- radiotherapy patient or non patient). On going&#xD;
      evaluation of technique MRI sequence and/or equipment etc should be carried out to determine&#xD;
      number of required volunteers with a maximum of 5 repeated imaging sessions per volunteer.&#xD;
      The TMG can restrict the maximum number of volunteers and repeated imaging sessions, if&#xD;
      appropriate.&#xD;
&#xD;
      A maximum of 150 volunteers will be recruited to this section of the study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Anticipated">January 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of the quality of imaging sequences assessed by a Visual Grading Analysis (VGA) (Stages A and B)</measure>
    <time_frame>12 months to build exam cards. Information gained after each cohort is recruited will build up in the definition of protocol imaging</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter observer registration variability (Stage C) based on the production of images of sufficient quality to allow for imaging matching and registration (assessed by validated image quality grading system)</measure>
    <time_frame>Assessment will be done for each imaging sequence available for each patient at each time point for imaging aquired up to one year.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra observer registration variability (Stage C) to assess the inter observer variability in assessment of tumour position between 4 assigned observers (target: a SD of variation of less than 3mm)</measure>
    <time_frame>Assessment will be done for each imaging sequence available for each patient at a specific time point. Up to 2 year recruitment period.</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">173</enrollment>
  <condition>Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>A) Volunteer Imaging Studies</arm_group_label>
    <description>Non-patient Volunteer Imaging Studies of Normal Tissue (n = 18 - 54) per centre In the first stage, participants will be non-patient volunteers who agree to undergo MR imaging on the MR Linac on a single or multiple occasions (up to 12) to examine the anatomic sites listed above for normal tissue visualisation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B) Patient Volunteer Imaging Studies</arm_group_label>
    <description>Patient Volunteer Imaging Studies of Normal Tissue (n = 39 - 72 per centre) In the second stage, participants will be patient volunteers, who agree to undergo MR imaging on the MR Linac on a single or multiple (up to 12) occasions to examine multiple tumour sites (n=11) for tumour/target visualisation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C) Pathway development studies</arm_group_label>
    <description>Pathway development studies (n = 39 - 208 per centre) In the third stage, participants will be patient volunteers, who agree to undergo MR imaging on the MR Linac on a single or multiple (up to 12) occasions to examine intra and inter observer variability on target and organs at risk visualisation using the exam cards from Stage B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D) On going imaging development &amp; quality improvement</arm_group_label>
    <description>This stage of the study will run in parallel or subsequent to stages B and C. The purpose will be to recruit patient or non-patient volunteers to help optimise MR guided radiotherapy delivery e.g. investigate radiotherapy immobilisation and equipment for patient positioning and set up development and/or development of new/novel imaging sequences, optimisation of existing sequences and undertaking continuing image quality improvement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Imaging</intervention_name>
    <description>This is an observational study only, with no interventions. Volunteers will undergo MRI imaging on the MR Linac, however this will not affect, change or initiate any intervention, or change to their care path.</description>
    <arm_group_label>A) Volunteer Imaging Studies</arm_group_label>
    <arm_group_label>B) Patient Volunteer Imaging Studies</arm_group_label>
    <arm_group_label>C) Pathway development studies</arm_group_label>
    <arm_group_label>D) On going imaging development &amp; quality improvement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There are 4 groups of participants:&#xD;
&#xD;
        A) Non-patient volunteers who will take part in non-patient volunteer imaging studies of&#xD;
        normal tissue.&#xD;
&#xD;
        B) Patient volunteers who will take part in imaging studies of normal tissue. C) Patient&#xD;
        volunteers who will take part in pathway development studies. D) non patient and patient&#xD;
        volunteers who will take part in on going image development and continuous quality&#xD;
        improvement of images&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All volunteers must undergo and satisfy MRI safety screening&#xD;
&#xD;
          -  Non-patient volunteers must have no known (or suspected) significant medical condition&#xD;
             and be 18 years of age&#xD;
&#xD;
          -  Patient volunteers must have histologically confirmed invasive carcinoma of the&#xD;
             tumour/target sites listed in this protocol and be under the care of a Clinical&#xD;
             Oncologist at the Royal Marsden NHS Foundation Trust or The Christie NHS Foundation&#xD;
             Trust and patients be planned to receive radiotherapy to target site to be imaged&#xD;
&#xD;
          -  All volunteers must be willing and able to provide informed consent/assent for the&#xD;
             study&#xD;
&#xD;
          -  Paediatric patient volunteers between the ages of 3 and 18 years, will have consent&#xD;
             provided by his or her legal guardian who is 18 years of age&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any conditions that would be a contra-indication to MRI including:&#xD;
&#xD;
          -  Failure to satisfy the MRI safety screening&#xD;
&#xD;
          -  Implanted pacemakers and/or pacing wires&#xD;
&#xD;
          -  Cochlear implants&#xD;
&#xD;
          -  Programmable hydrocephalus shunts&#xD;
&#xD;
          -  Implanted neurostimulation systems&#xD;
&#xD;
          -  Implanted drug infusion pumps&#xD;
&#xD;
          -  Ferromagnetic implants And additional conditions that may place volunteers at&#xD;
             increased risk from MRI procedures including:&#xD;
&#xD;
          -  Known susceptibility to seizures or migraines&#xD;
&#xD;
          -  Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body&#xD;
             temperature (for example pregnant women)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Huddart</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Cancer Research, United Kingdom</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorna Bower</last_name>
    <phone>+44 208 661 3561</phone>
    <phone_ext>1119</phone_ext>
    <email>lorna.bower@rmh.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorna Bower</last_name>
      <phone>+442086613434</phone>
      <email>lorna.bower@icr.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Robert Huddart</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</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>Adenocarcinoma</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/NCT02973828
org study id: CCR4576
nct id: NCT02973828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment
      to locate the tumour and ensure the radiation is hitting the target.

      These x-rays expose patients to additional radiation and the quality of these scans is often
      poor which makes it difficult to distinguish tumour from normal tissue and there may be
      uncertainty in the tumour position due to movement or shrinkage. To allow for these
      uncertainties a large margin around the tumour is also treated, but this means that large
      volumes of normal tissue also receive significant doses of radiation, which can result in
      early and late toxicity.

      MRI (magnetic resonance imaging) is better than CT scanning at being able to tell the
      difference between tumour and normal tissues and does not expose patients to additional
      radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear
      accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the
      Institute of Cancer Research (ICR)/The Royal Marsden Hospital (RMH) are currently
      installation a prototype, which will be one of the first in the world. This revolutionary
      technology has the potential to change the way radiotherapy is delivered. We hope the
      improved precision and accuracy in hitting the target will mean reductions in margins around
      tumours and that this will lead to higher cure rates with significantly fewer side effects.
      Studies are required to simulate treatment on the MR Linac before it can be used in routine
      clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and
      patients who are currently undergoing treatment. This study will involve imaging with MRI in
      healthy volunteers as well as in patient volunteers before and during their standard course
      of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR
      Linac-based research focusing on clinical application and establishment into a MR-CT and MR
      only workflow, treatment adaptation and quality assurance.
This is a study protocol for the acquisition of MR Linac derived images with a view to MRIgRT
      for patients undergoing radiotherapy with radical intent at sites predicted to benefit most
      from MRIgRT (namely, for rectum, cervix, lung, prostate, bladder, breast, brain, oesophagus,
      head and neck, hepato-pancreato-biliary (HPB) and paediatric abdomino-thoracic cancers).
      These will be used to build a database of MR images for MR Linac-based research focusing on
      clinical application and establishment into a MR-CT and MR only workflow, treatment
      adaptation and quality assurance. The primary aims are to 1) develop MR Linac image sequences
      suitable for seeing tumour/target and normal tissue at the time of radiotherapy and 2)
      determine variations in image registrations and tissue contouring using the MR Linac images.
      Four stages of imaging development sub-studies will be included in this protocol for
      optimisation of MR imaging on the MR Linac. Consideration will be given to image quality,
      scan times, and IT requirements for reconstruction, storage and image transfer.

      These imaging sub-studies will be:

      A) Non-patient Volunteer Imaging Studies of Normal Tissue (n = 18 - 54 per centre). The four
      anatomical regions selected to be studied are Head and neck, Thorax (chest wall/breast and
      lung/oesophagus), Abdomen and Pelvis (male and female). Recruitment will continue until
      imaging from a minimum of three consecutive patients using the same 'exam card' are deemed to
      be acceptable for normal tissue visualisation for each anatomical site.

      B) Patient Volunteer Imaging Studies of Normal Tissue (n = 39 - 72 per centre). We will
      further develop the protocols to visualise site specific tumours in 13 target areas (brain,
      oropharynx/larynx/hypopharynx, oesophagus, lung, chest wall _+/- regional lymph nodes),
      paediatric abdomen-thoracic cancers, hepatobiliary tract, bladder, gynaecology, prostate,
      rectum, oligomets bone and oliogmets soft tissue). Patients will be recruited for imaging for
      a minimum of one and maximum of 12 imaging sessions whilst undergoing radiotherapy planning
      and/or radiotherapy treatment. Repeat imaging will allow for the determination of protocol
      robustness. The aim will be to produce images appropriate for tumour and normal tissue
      visualisation with a view to directing radiotherapy. Recruitment will continue until imaging
      from a minimum of three consecutive patients using the same 'exam card' are deemed to be
      acceptable for tumour/target visualisation at each site.

      C) Pathway development studies (n = 39 - 208 per centre). At each centre, it is estimated
      that 16 imaging sessions per tumour site are required for inter and intra registration
      observer variability. To establish library of images to be used to develop adaptive
      radiotherapy workflows, up to 50 imaging sessions may be required depending on the tumour
      site. Images for normal tissue and tumour visualisation will also be used to refine exam
      cards from Stage B.

      This stage requires a minimum of three patient volunteers to be recruited to each tumour site
      which may (or may not) include images acquired in the previous Stage B of the study, and a
      maximum of 16 patient volunteers to reach the desired number of imaging sessions. Each
      volunteer should undergo a minimum of two and not more than twelve imaging sessions (max
      1/day, 3/week). The methodology of image acquisition will follow methodology for Stage B as
      above. The primary aim will be to establish that both online and offline image-matching using
      MR Linac with a view to guiding radiotherapy treatments can be undertaken with minimal intra
      and inter user variability. Development of treatment workflow to help implement radiotherapy
      treatment on the MR Linac can also be carried out. Refined exam cards from Stage B but fine
      tuning as necessary can be used to acquire sets of images and to use this information to plan
      treatment by simulating an on-line treatment whilst not delivering radiation.

      D) On-going image development and continuous quality improvement of images

      This stage of the study can run in parallel, subsequent to or independently of stages B and
      C. The purpose will be to recruit patients receiving radiotherapy, non-radiotherapy cancer
      patients or non-patient volunteers in order to optimise MRI guided radiotherapy delivery.
      Examples of this include, investigating suitability of radiotherapy immobilisation devices
      for patient positioning and treatment set-up development and/or development of new/novel
      imaging sequences, optimisation of existing sequences and undertaking continuing image
      quality improvement for the tumour sites listed in this protocol. Adult patient with cancers
      not conventionally treated using radiotherapy could be recruited in order to investigate
      whether radiotherapy could be used as a treatment modality in the future. Patients with
      unusual or rare cancer (for example sarcoma, kidney and lymphoma) that do receive
      radiotherapy could be recruited to investigate the benefit of using the MR Linac for cancers
      of this type.

      The total number of volunteers is, as yet, unknown; however the recruitment progress will be
      monitored by the trial management group (TMG). The TMG will ensure that this protocol is
      being adhered to, that all volunteers are being imaged safely and that the information gained
      from the imaging sessions is being used appropriately. The investigator may recruit between
      one and five volunteers (patient, non- radiotherapy patient or non patient). On going
      evaluation of technique MRI sequence and/or equipment etc should be carried out to determine
      number of required volunteers with a maximum of 5 repeated imaging sessions per volunteer.
      The TMG can restrict the maximum number of volunteers and repeated imaging sessions, if
      appropriate.

      A maximum of 150 volunteers will be recruited to this section of the study
observational model: Case-Only
time perspective: Prospective
measure: Acceptability of the quality of imaging sequences assessed by a Visual Grading Analysis (VGA) (Stages A and B)
time frame: 12 months to build exam cards. Information gained after each cohort is recruited will build up in the definition of protocol imaging
measure: Inter observer registration variability (Stage C) based on the production of images of sufficient quality to allow for imaging matching and registration (assessed by validated image quality grading system)
time frame: Assessment will be done for each imaging sequence available for each patient at each time point for imaging aquired up to one year.
measure: Intra observer registration variability (Stage C) to assess the inter observer variability in assessment of tumour position between 4 assigned observers (target: a SD of variation of less than 3mm)
time frame: Assessment will be done for each imaging sequence available for each patient at a specific time point. Up to 2 year recruitment period.
arm group label: A) Volunteer Imaging Studies
description: Non-patient Volunteer Imaging Studies of Normal Tissue (n = 18 - 54) per centre In the first stage, participants will be non-patient volunteers who agree to undergo MR imaging on the MR Linac on a single or multiple occasions (up to 12) to examine the anatomic sites listed above for normal tissue visualisation.
arm group label: B) Patient Volunteer Imaging Studies
description: Patient Volunteer Imaging Studies of Normal Tissue (n = 39 - 72 per centre) In the second stage, participants will be patient volunteers, who agree to undergo MR imaging on the MR Linac on a single or multiple (up to 12) occasions to examine multiple tumour sites (n=11) for tumour/target visualisation.
arm group label: C) Pathway development studies
description: Pathway development studies (n = 39 - 208 per centre) In the third stage, participants will be patient volunteers, who agree to undergo MR imaging on the MR Linac on a single or multiple (up to 12) occasions to examine intra and inter observer variability on target and organs at risk visualisation using the exam cards from Stage B.
arm group label: D) On going imaging development & quality improvement
description: This stage of the study will run in parallel or subsequent to stages B and C. The purpose will be to recruit patient or non-patient volunteers to help optimise MR guided radiotherapy delivery e.g. investigate radiotherapy immobilisation and equipment for patient positioning and set up development and/or development of new/novel imaging sequences, optimisation of existing sequences and undertaking continuing image quality improvement.
intervention type: Procedure
intervention name: Imaging
description: This is an observational study only, with no interventions. Volunteers will undergo MRI imaging on the MR Linac, however this will not affect, change or initiate any intervention, or change to their care path.
arm group label: A) Volunteer Imaging Studies
arm group label: B) Patient Volunteer Imaging Studies
arm group label: C) Pathway development studies
arm group label: D) On going imaging development & quality improvement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Huddart
role: Principal Investigator
affiliation: Institute of Cancer Research, United Kingdom
last name: Lorna Bower
phone: +44 208 661 3561
phone ext: 1119
email: lorna.bower@rmh.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Adenocarcinoma