Using a non-magnetic screen to guide breathing during MRI-guided radiotherapy for mobile cancerous lesions
Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
This study is testing if using a special non-magnetic screen during MRI-guided radiotherapy can help patients with mobile cancerous lesions breathe better and improve their treatment experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Months and up |
| Sex | All |
| Sponsor | Centre Georges Francois Leclerc Academic / other |
| Locations | 1 site (Dijon, Côte d'Or) |
| Trial ID | NCT05783908 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a non-magnetic screen on patient breathing guidance during MRI-guided radiotherapy sessions for mobile cancerous lesions, such as those in the pancreas, liver, kidneys, and adrenals. Patients will be randomized into two groups: one receiving standard treatment without the screen and the other with the screen in place. The study aims to assess whether the screen can reduce the discrepancy between actual and predicted treatment times. Participants will undergo five sessions of radiotherapy, with evaluations of anxiety, stress, patient satisfaction, pain intensity, and respiratory effort conducted throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are starting radiotherapy on Linac MRI for mobile cancerous lesions.
Not a fit: Patients with lesions not detectable by the tracking system or those with contraindications to MRI treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the efficiency of radiotherapy sessions and improve patient comfort and outcomes.
How similar studies have performed: While the specific use of a non-magnetic screen in this context is novel, similar approaches in improving patient guidance during radiotherapy have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon, Côte d'Or
- Centre Georges-François Leclerc — Dijon, Côte d'Or, France (Recruiting)
Study contacts
- Study coordinator: Gilles TRUC, Doctor
- Email: gtruc@cgfl.fr
- Phone: 03 80 73 75 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.