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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06994702
Acronym
ISTRI
Enrollment
3
Registered
2025-05-29
Start date
2025-05-19
Completion date
2025-08-26
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Device Ineffective

Keywords

Synthetic CT, MRI

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.

Interventions

DEVICEMRI without mask

MRI in position of cerebral radiotherapy treatment without mask

DEVICEMRI with mask 1

MRI in position of cerebral radiotherapy treatment with mask 1

DEVICEMRI with mask 2

MRI in position of cerebral radiotherapy treatment with mask 2

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate quality of a synthetic scanner generated from an MRI performed in the position of cerebral radiotherapy treatment with 2 thermoformed masks1 dayThe quality is measured in Hounsfield Units (HU) on each of the structures outlined on the MRI scans and reproduced on the sCT scans.

Secondary

MeasureTime frameDescription
Comparison of the quality of MRI images with and without restraint1 dayMesure of signal-to-noise ratio (SNR)
Studying the integration of a field map into routine clinical practice1 dayMeasurement of acquisition

Countries

France

Contacts

PRINCIPAL_INVESTIGATORStéphane DUFRENAIX

Institut de Cancérologie de l'Ouest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026