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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • With non-magnetic screen

    Combination product

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Without Non-magnetic screenNo intervention 0 interventions
Group B: With non-magnetic screenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine).

To evaluate the effect of a non-magnetic screen visible to the patient in the bunker during radiation therapy sessions delivered by Linac MRI on decreasing the ratio of actual treatment time to the treatment time predicted by the machine.

Time frame
During 25 months

Secondary outcomes

1

Patient respiratory effort with visual analog scale

Patient respiratory effort for each radiotherapy session according to randomization arm. The scale is graduated from 0 to 10 with 10 = maximum respiratory discomfort and 0 = no respiratory discomfort

Time frame
During 25 months
2

The positional pain with visual analog scale

Compare the positional pain associated with setting up on the treatment table for each radiation therapy session according to the randomization arm. The scale is graduated from 0 to 10 with 0 = absence of pain and 10 = maximum pain

Time frame
During 25 months
3

Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid

To assess the average level of anxiety/stress for each radiation therapy session according to the randomization arm. The Spielberg scale via the STAI-form Y-A grid is used before each treatment session in order to follow the evolution of the patients' emotional state. 20 questions with 4 possible answers : 1/ Not at all, 2/ A little, 3/Moderately , 4/ A lot.

Time frame
During 25 months
4

The potential time

Evaluate whether the potential time savings in screen time compensates for the time spent learning the screen during the simulation.

Time frame
During 25 months

Other outcomes

Sponsors and contacts

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