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NCT Number: NCT05783908

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

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.

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Key information

Conditions

Patient With Radiotherapy (Linac MRI) Adrenal Gland Diseases Adrenal Gland Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Mobile Cancerous Lesion Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

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).

    Time frame: During 25 months

    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.

Secondary outcomes

  1. Patient respiratory effort with visual analog scale

    Time frame: During 25 months

    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

  2. The positional pain with visual analog scale

    Time frame: During 25 months

    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

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

    Time frame: During 25 months

    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.

  4. The potential time

    Time frame: During 25 months

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

  5. The patient satisfaction evaluated with an ad-hoc questionnaire.

    Time frame: During 25 months

    The patient's satisfaction with his or her involvement in the treatment process will be evaluated at the end of the 5 radiotherapy sessions using an ad-hoc questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Gilles TRUC, Doctor

CONTACT

[email protected]

03 80 73 75 18 ext. +33

Sophie PARNALLAND, Project Manager

CONTACT

[email protected]

03 45 34 80 77 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: RespEcran

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2023
Registry last updated
Feb 17, 2025

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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