Prospective Evaluation of Radiotherapy Using Magnetic Res... | NCT03727698

Studies
Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment

NCT03727698

Sponsor

Institute of Cancer Research, United Kingdom

Status

Unknown status

Last Update Posted

Nov 7, 2019Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

MR Linac

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2019Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Oct 31, 2018

First Submission Date that Met QC Criteria

Oct 31, 2018

First Posted Date

Nov 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2019

Last Update Posted Date

Nov 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy delivered on the MR Linac	Experimental	MR Guided radiotherapy treatment	Device: MR Linac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR Linac	Device	MR guided radiotherapy treatment	Radiotherapy delivered on the MR Linac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Huddart	Contact	44 208 661 3425		robert.huddart@icr.ac.uk
Lorna Bower, BSc	Contact			lorna.bower@icr.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden NHSFT	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided