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Recruiting NCT05783908

Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions

No phase Interventional Patient With Radiotherapy (Linac MRI) Mobile Cancerous Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: With non-magnetic screen.
Who it may be relevant to
Registry conditions: Patient With Radiotherapy (Linac MRI), Mobile Cancerous Lesion. Basic parameters: from 18 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...). After signing the consent form, each patient will be randomized to one of two treatment arms: * Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding * Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.

Detailed description

The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).

After signing the consent form, each patient will be randomized to one of two treatment arms:

* Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding * Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen

The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff)

The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study

Before each session will be assessed for anxiety and stress. After each session will be evaluated patient satisfaction, pain intensity and respiratory effort.

The duration of the treatment and therefore of the follow-up of the patient in the study is 1 to 2 weeks

Interventions

  • Combination product With non-magnetic screen
    Radiotherapy treatment with Linac MRI is performed with a non-magnetic screen that will guide the patient to block the breathing

Primary outcome measures

  • The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine). [Time frame: During 25 months]
Secondary outcome measures (5)
  • Patient respiratory effort with visual analog scale [Time frame: During 25 months]
  • The positional pain with visual analog scale [Time frame: During 25 months]
  • Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid [Time frame: During 25 months]
  • The potential time [Time frame: During 25 months]
  • The patient satisfaction evaluated with an ad-hoc questionnaire. [Time frame: During 25 months]

Eligibility criteria

Inclusion criteria

  • Patient is at least 18 years old
  • Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy
  • Patient affiliated to the social security system

Exclusion criteria

  • Patient with lesions not detected by the device's tracking system
  • Patient with visual disturbances
  • Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI)
  • Patients with cognitive disorders
  • Persons deprived of liberty or under guardianship (including curatorship)
  • Pregnant or nursing woman
  • Refusal to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

France · 1 center
  • Centre Georges-François Leclerc — Dijon

Identifiers

NCT: NCT05783908 · 2022-A02774-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗