Impact of the MRI Restraint System on the Quality of the... | NCT06994702

Studies
Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment

NCT06994702

Sponsor

Institut Cancerologie de l'Ouest

Status

Completed

Last Update Posted

Mar 10, 2026Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Device Ineffective

Interventions

MRI without mask
MRI with mask 1
MRI with mask 2

Countries

France

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2025Actual

Primary Completion Date

Aug 26, 2025Actual

Completion Date

Aug 26, 2025Actual

First Submitted Date

Apr 8, 2025

First Submission Date that Met QC Criteria

May 20, 2025

First Posted Date

May 29, 2025Actual

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

Mar 9, 2026

Last Update Posted Date

Mar 10, 2026Actual

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

In radiotherapy, CT scans are the reference imaging tool for treatment planning, as they provide the electron density of the tissues required to calculate the dose. Magnetic Resonance Imaging (MRI) is used as a complement to CT to contour target volumes and organs at risk. While the properties of CT allow us to determine the electron density of tissues, the properties of MRI allow us to determine the proton density of tissues. MRI therefore provides better tissue contrast, but cannot be used directly to calculate the dose. In recent years, MRI-only protocols have been introduced to remove the need for a CT examination and avoid possible MRI-CT registration errors. Dose calculations are then performed on MRI images converted into synthetic CT images (sCT) using software based on artificial intelligence (for the most recent). Various commercial solutions are available for generating these sCTs, and the ICO already has experience of evaluating them.

While MRI scans for diagnostic purposes are performed in the free position, the generation of an sCT for treatment preparation requires the MRI scan to be performed in the radiotherapy position. For cranial lesions, a thermoformed mask fixed to the table is made for each patient. Depending on the type of treatment and its associated degree of precision, different types of mask exist at the ICO: '3-point' for normo-fractionated treatments and 'stereo' for treatments of 1 to 3 fractions. The use of these masks during the MRI examination can interfere with the correct positioning of the antennae and thus lead to a deterioration in the quality of the images obtained (MRI and, by repercussion, sCT).

The aim of this study was to evaluate the impact of the 2 thermoformed masks used at the ICO on the quality of a synthetic scan for 3 healthy volunteers.

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI with thermoformed masks	Experimental	MRI performed in the position of cerebral radiotherapy treatment	Device: MRI without mask Device: MRI with mask 1 Device: MRI with mask 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI without mask	Device	MRI in position of cerebral radiotherapy treatment without mask	MRI with thermoformed masks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks	The quality is measured in Hounsfield Units (HU) on each of the structures outlined on the MRI scans and reproduced on the sCT scans.	1 day

Secondary Outcomes

Measure	Description	Time Frame
Comparison of the quality of MRI images with and without restraint	Mesure of signal-to-noise ratio (SNR)	1 day
Comparison of the quality of MRI images with and without restraint	Mesure of contrast-to-noise ratio (CNR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male > 18 years
Health professional practising at the ICO
Volunteer who has signed the consent form
Volunteer available to carry out the 3 MRI scans

Exclusion Criteria:

Claustrophobia
Foreign metal objects (metal splinters, filings, shotgun pellets, etc.)
Woman

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stéphane DUFRENAIX	Institut de Cancérologie de l'Ouest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Cancerologie de L'Ouest		Angers		49055	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008397	Masks

Ancestor Terms

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D011482	Protective Devices

Browse Leaves

Not provided

Browse Branches

Not provided