CancerPERMITNCT03727698
Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment
A study testing MR Linac in people with Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- MR Linac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2019to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Radiotherapy treatment suitable to be delivered on the MR Linac.
- Patient provides written, informed consent and/or authorization.
- Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent.
Who cannot join
- Contra-indications to MR imaging.
- Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).
Trial locations and contacts
1 site in 1 country.
Lorna Bower, BSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHSFT
London
Robert Huddart
Robert Huddart
About this study
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
- Conditions
- Cancer
- Being tested
- MR Linac
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR LinacDevice
MR guided radiotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy delivered on the MR Linac | Experimental | MR Guided radiotherapy treatment Receives: Device: MR Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of undertaking MRL based radiotherapy at multiple clinical sites: The percentage of treatment fractions delivered successfully on the MR linac
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start11 Jan 2019
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727698
- Sponsor's protocol ID
- CCR4841
- Acronym
- PERMIT
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2018
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared within the academic and industrial partners. All data sharing would be dependant on appropriate data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment
- ClinicalTrials.gov ID
- NCT03727698
- Acronym / sponsor ID
- PERMIT / CCR4841
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy delivered on the MR Linac | Experimental | Device: MR LinacMR Guided radiotherapy treatment |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Radiotherapy treatment suitable to be delivered on the MR Linac.
- Patient provides written, informed consent and/or authorization.
- Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent.
Key exclusion criteria (2 listed)
- Contra-indications to MR imaging.
- Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR LinacMR guided radiotherapy treatment | Device | Radiotherapy delivered on the MR Linac |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared within the academic and industrial partners. All data sharing would be dependant on appropriate data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Bower, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Linac in people with Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Huddart (44 208 661 3425, robert.huddart@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.