Clinical trial NCT06994702: Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment
Official title: Evaluation of the Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment: Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Device Ineffective
Keywords: Synthetic CT
MRI
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of the quality of MRI images with and without restraint
timeFrame: 1 day
measure: Comparison of the quality of MRI images with and without restraint
timeFrame: 1 day
measure: Studying the integration of a field map into routine clinical practice
timeFrame: 1 day
measure: Studying the integration of a field map into routine clinical practice
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Stéphane DUFRENAIX
role: PRINCIPAL_INVESTIGATOR
References: