Pelvic Cancer, Rectum Cancer
Conditions
Keywords
Repeatability, Reproducibility, MR-Linac, Radiotherapy, Functional MRI
Brief summary
This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.
Detailed description
Volunteers will be required to complete a questionnaire to ensure their eligibility and safety for undergoing an MRI. This questionnaire, along with safety information, will be reviewed before each MR session. Subsequently, volunteers will undergo three MRI sessions, ideally two on the same day, with the last session scheduled 10 to 17 days apart from the previous ones. Each session is expected to last approximately 60 minutes (several sequences), and no contrast agent will be injected at any point. On the first day, volunteers will have an MRI on the 1.5 Tesla MR-Linac Unity (Elekta device) and an MRI on a standard 1.5 Tesla MRI (Siemens). Between days 10 to 17, they will exclusively undergo an MR-Linac session.
Interventions
DEVICEMagnetic Resonance Imaging (MRI)
\- Three MRI : * two on an MR-Linac 1.5 Tesla (10 to 17 days apart) * one on a standard 1.5 Tesla MRI
Sponsors
Jules Bordet Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 yo * Healthy * Volunteer * Ability to undergo an MRI
Exclusion criteria
* \< 18yo * Contraindication to undergoing an MRI (see safety questionnaire) * Previous pelvic irradiation * Pelvic pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the repeatability coefficient (RC) (percentage) | Day 1 and Day 10-17 | Quantitative assessment of the Repeatability Coefficient for functional MRI sequences in rectal tissue, expressed as a percentage. |
| Assess the reproducibility coefficient (RDC) (percentage) | Day 1 and Day 10-17 | Comparative analysis of Repeatability Coefficient values obtained from distinct MRI devices, providing insights into device-specific variations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of variation between the different calculation Methods for Repeatability Coefficient. | Day 1 and Day 10-17 | Comparative evaluation of different calculation methods for the Repeatability Coefficient, highlighting the consistency and discrepancies among methods. |
| Percentage of variation across various pelvic organs for Repeatability Coefficient. | Day 1 and Day 10-17 | Exploration of Repeatability Coefficients in different pelvic organs, providing insights into the variability of repeatability across distinct anatomical structures. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of variation based on sequence types for the Repeatability Coefficients. | Day 1 and Day 10-17 | Comparative assessment of Repeatability Coefficients across different types of functional MRI sequences, elucidating the impact of sequence variations on repeatability. |
Contacts
Primary ContactMadeline A Michel, MD
Backup ContactClemence Al Wardi, PhD
Outcome results
None listed