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Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment (PERMIT)

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: NCT03727698
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Brief Summary:

The purpose of PERMIT is to collect information on the treatment of radiotherapy patients using a new radiotherapy machine that includes magnetic Resonance (MR) imaging (MR linac) to guide treatment. The aim is to use this information to support the introduction of MR Linac into clinical practice.

PERMIT will collect details on patients treated on the MR linac plus details on their side effects and other outcomes. This information plus technical and imaging information will be combined with information from other centres using this machine. By doing so this will help us learn how best to use the MR Linac in the future and design new radiotherapy protocols


Condition or disease Intervention/treatment Phase
Cancer Device: MR Linac Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2025

Arm Intervention/treatment
Experimental: Radiotherapy delivered on the MR Linac
MR Guided radiotherapy treatment
Device: MR Linac
MR guided radiotherapy treatment




Primary Outcome Measures :
  1. Technical feasibility of undertaking MRL based radiotherapy at multiple clinical sites: The percentage of treatment fractions delivered successfully on the MR linac [ Time Frame: 2 years ]
    The percentage of treatment fractions delivered successfully on the MR linac, if more than 20 % of patients (depending on treatment site) need to be treated on alternative machine or treatment protocol changed will lead to the MRL protocol at that site to be judged not feasible.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Radiotherapy treatment suitable to be delivered on the MR Linac.
  2. Patient provides written, informed consent and/or authorization.
  3. Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent.

Exclusion Criteria:

  1. Contra-indications to MR imaging.
  2. Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).

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): NCT03727698


Contacts
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Contact: Robert Huddart 44 208 661 3425 robert.huddart@icr.ac.uk
Contact: Lorna Bower, BSc lorna.bower@icr.ac.uk

Locations
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United Kingdom
Royal Marsden NHSFT Recruiting
London, United Kingdom
Contact: Robert Huddart         
Principal Investigator: Robert Huddart         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom

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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT03727698    
Other Study ID Numbers: CCR4841
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be shared within the academic and industrial partners. All data sharing would be dependant on appropriate data sharing agreements.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No