NCT03727698

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

4.8 years

First QC Date

October 31, 2018

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (1)

Radiotherapy delivered on the MR Linac

EXPERIMENTAL

MR Guided radiotherapy treatment

Device: MR Linac

Interventions

MR LinacDEVICE

MR guided radiotherapy treatment

Radiotherapy delivered on the MR Linac

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHSFT

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Lorna Bower, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To assess delivery of radiotherapy on the MR Linac for multiple tumour sites
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 1, 2018

Study Start

January 11, 2019

Primary Completion

November 1, 2023

Study Completion

November 1, 2025

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared within the academic and industrial partners. All data sharing would be dependant on appropriate data sharing agreements.

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations