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

NCT06994702 — Not applicable, Completed, 3 participants, Institut Cancerologie de l'Ouest

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Evaluation of the Impact of the MRI Restraint System on the Quality of the Synthetic Scan for Intracranial Radiotherapy Treatment: Feasibility Study

RegistryNCT06994702, acronym ISTRI
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, device feasibility
Enrollment3 (Actual)
SponsorInstitut Cancerologie de l'Ouest (Other)
ConditionsDevice Ineffective
InterventionsMRI without mask, MRI with mask 1, MRI with mask 2 (Device)
Datesstart 2025-05-19, primary completion 2025-08-26, completion 2025-08-26, first posted 2025-05-29, last updated 2026-03-10
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Device Ineffective All trials of MRI without mask All trials of MRI with mask 1

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
MRI with thermoformed masksExperimentalDevice: MRI without mask; Device: MRI with mask 1; Device: MRI with mask 2MRI performed in the position of cerebral radiotherapy treatment
  • MRI without mask (Device): MRI in position of cerebral radiotherapy treatment without mask
  • MRI with mask 1 (Device): MRI in position of cerebral radiotherapy treatment with mask 1
  • MRI with mask 2 (Device): MRI in position of cerebral radiotherapy treatment with mask 2

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Comparison of the quality of MRI images with and without restraint [1 day]: Mesure of signal-to-noise ratio (SNR)
  • Comparison of the quality of MRI images with and without restraint [1 day]: Mesure of contrast-to-noise ratio (CNR)
  • Studying the integration of a field map into routine clinical practice [1 day]: Measurement of acquisition
  • Studying the integration of a field map into routine clinical practice [1 day]: Measurement of analysis time

+Eligibility

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Institut de Cancerologie de L'OuestAngersFrance

+Investigators

  • StĂ©phane DUFRENAIX, Principal investigator, Institut de CancĂ©rologie de l'Ouest