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

NCT06994702 | Completed

• 1 other identifier: ICO-2024-24
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Ineffective

Keywords

Synthetic CT; MRI

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Comparison of the quality of MRI images with and without restraint

  1 day

• Comparison of the quality of MRI images with and without restraint

  1 day

• Studying the integration of a field map into routine clinical practice

  1 day

• Studying the integration of a field map into routine clinical practice

  1 day

Study Arms (1)

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

MRI without mask DEVICE

MRI in position of cerebral radiotherapy treatment without mask

MRI with thermoformed masks

MRI with mask 1 DEVICE

MRI in position of cerebral radiotherapy treatment with mask 1

MRI with thermoformed masks

MRI with mask 2 DEVICE

MRI in position of cerebral radiotherapy treatment with mask 2

MRI with thermoformed masks

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stéphane DUFRENAIX

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 29, 2025
• Study Start: May 19, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)