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CompletedNCT06994702ISTRIUpdated Mar 10, 2026

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

An interventional study of MRI without mask and MRI with mask 1 in Device Ineffective, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Device Ineffective

Keywords

  • Synthetic CT
  • MRI
03

In context

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

Exclusion Criteria:

  1. Claustrophobia
  2. Foreign metal objects (metal splinters, filings, shotgun pellets, etc.)
  3. Woman
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    MRI with thermoformed masks

    MRI performed in the position of cerebral radiotherapy treatment

    Device: MRI without mask · Device: MRI with mask 1 · Device: MRI with mask 2

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

06

What researchers measure

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.

    Time frame: 1 day

Secondary outcomes

  1. Comparison of the quality of MRI images with and without restraint

    Mesure of signal-to-noise ratio (SNR)

    Time frame: 1 day

  2. Comparison of the quality of MRI images with and without restraint

    Mesure of contrast-to-noise ratio (CNR)

    Time frame: 1 day

  3. Studying the integration of a field map into routine clinical practice

    Measurement of acquisition

    Time frame: 1 day

  4. Studying the integration of a field map into routine clinical practice

    Measurement of analysis time

    Time frame: 1 day

07

Study locations

1 site
  • Institut de Cancerologie de L'Ouest
    Angers, 49055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06994702
Lead sponsor
Institut Cancerologie de l'Ouest
Responsible party
Sponsor
First posted
May 29, 2025
Start date
May 19, 2025
Primary completion
Aug 26, 2025
Completion
Aug 26, 2025
Last update
Mar 10, 2026

Study contacts

Stéphane DUFRENAIX
principal investigator · Institut de Cancérologie de l'Ouest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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