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2023-10-16
2025-09-27
2025-09-27
100
NCT05783908
Centre Georges Francois Leclerc
Centre Georges Francois Leclerc
INTERVENTIONAL
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-02-10 | N/A | 2025-02-14 |
2023-03-23 | N/A | 2025-02-17 |
2023-03-24 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| NO_INTERVENTION: Without Non-magnetic screen Radiotherapy treatment with Linac MRI without non-magnetic shielding | |
| EXPERIMENTAL: With non-magnetic screen Radiotherapy treatment with Linac MRI with non-magnetic screen | COMBINATION_PRODUCT: With non-magnetic screen
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | During 25 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | During 25 months |
| 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 | During 25 months |
| 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. | During 25 months |
| The potential time | Evaluate whether the potential time savings in screen time compensates for the time spent learning the screen during the simulation. | During 25 months |
| The patient satisfaction evaluated with an ad-hoc questionnaire. | 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. | During 25 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Gilles TRUC, Doctor Phone Number: 03 80 73 75 18 Email: gtruc@cgfl.fr |
Study Contact Backup Name: Sophie PARNALLAND, Project Manager Phone Number: 03 45 34 80 77 Email: sparnalland@cgfl.fr |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Months
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
