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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Device Ineffective

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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MRI with thermoformed masks

MRI performed in the position of cerebral radiotherapy treatment

Group Type EXPERIMENTAL

MRI without mask

Intervention Type DEVICE

MRI in position of cerebral radiotherapy treatment without mask

MRI with mask 1

Intervention Type DEVICE

MRI in position of cerebral radiotherapy treatment with mask 1

MRI with mask 2

Intervention Type DEVICE

MRI in position of cerebral radiotherapy treatment with mask 2

Interventions

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MRI without mask

MRI in position of cerebral radiotherapy treatment without mask

Intervention Type DEVICE

MRI with mask 1

MRI in position of cerebral radiotherapy treatment with mask 1

Intervention Type DEVICE

MRI with mask 2

MRI in position of cerebral radiotherapy treatment with mask 2

Intervention Type DEVICE

Eligibility Criteria

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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