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Completed

NCT Number: NCT06994702

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

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

    Time frame: 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

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

    Time frame: 1 day

    Mesure of signal-to-noise ratio (SNR)

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

    Time frame: 1 day

    Mesure of contrast-to-noise ratio (CNR)

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

    Time frame: 1 day

    Measurement of acquisition

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

    Time frame: 1 day

    Measurement of analysis time

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: ISTRI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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