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PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973828
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Brief Summary:

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.


Condition or disease Intervention/treatment
Adenocarcinoma Procedure: Imaging

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Study Type : Observational
Estimated Enrollment : 173 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT)
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A) Volunteer Imaging Studies
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.
Procedure: Imaging
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.

B) Patient Volunteer Imaging Studies
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.
Procedure: Imaging
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.

C) Pathway development studies
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.
Procedure: Imaging
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.

D) On going imaging development & quality improvement
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.
Procedure: Imaging
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

There are 4 groups of participants:

A) Non-patient volunteers who will take part in non-patient volunteer imaging studies of normal tissue.

B) Patient volunteers who will take part in imaging studies of normal tissue. C) Patient volunteers who will take part in pathway development studies. D) non patient and patient volunteers who will take part in on going image development and continuous quality improvement of images

Criteria

Inclusion Criteria:

  • All volunteers must undergo and satisfy MRI safety screening
  • Non-patient volunteers must have no known (or suspected) significant medical condition and be 18 years of age
  • Patient volunteers must have histologically confirmed invasive carcinoma of the tumour/target sites listed in this protocol and be under the care of a Clinical Oncologist at the Royal Marsden NHS Foundation Trust or The Christie NHS Foundation Trust and patients be planned to receive radiotherapy to target site to be imaged
  • All volunteers must be willing and able to provide informed consent/assent for the study
  • Paediatric patient volunteers between the ages of 3 and 18 years, will have consent provided by his or her legal guardian who is 18 years of age
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

Any conditions that would be a contra-indication to MRI including:

  • Failure to satisfy the MRI safety screening
  • Implanted pacemakers and/or pacing wires
  • Cochlear implants
  • Programmable hydrocephalus shunts
  • Implanted neurostimulation systems
  • Implanted drug infusion pumps
  • Ferromagnetic implants And additional conditions that may place volunteers at increased risk from MRI procedures including:
  • Known susceptibility to seizures or migraines
  • Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body temperature (for example pregnant women)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973828


Contacts
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Contact: Lorna Bower +44 208 661 3561 ext 1119 lorna.bower@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Lorna Bower    +442086613434    lorna.bower@icr.ac.uk   
Principal Investigator: Robert Huddart         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
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Principal Investigator: Robert Huddart Institute of Cancer Research, United Kingdom
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02973828    
Other Study ID Numbers: CCR4576
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms