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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers | Other | Single arm of volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Device | - Three MRI :
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the repeatability coefficient (RC) (percentage) | Quantitative assessment of the Repeatability Coefficient for functional MRI sequences in rectal tissue, expressed as a percentage. | Day 1 and Day 10-17 |
| Assess the reproducibility coefficient (RDC) (percentage) | Comparative analysis of Repeatability Coefficient values obtained from distinct MRI devices, providing insights into device-specific variations. | Day 1 and Day 10-17 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of variation between the different calculation Methods for Repeatability Coefficient. | Comparative evaluation of different calculation methods for the Repeatability Coefficient, highlighting the consistency and discrepancies among methods. | Day 1 and Day 10-17 |
| Percentage of variation across various pelvic organs for Repeatability Coefficient. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of variation based on sequence types for the Repeatability Coefficients. | Comparative assessment of Repeatability Coefficients across different types of functional MRI sequences, elucidating the impact of sequence variations on repeatability. | Day 1 and Day 10-17 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madeline A Michel, MD | Contact | 0032 2 541 39 15 | madeline.michel@hubruxelles.be | |
| Clemence Al Wardi, PhD | Contact | 0032 2 541 39 81 | clemence.alwardi@hubruxelles.be |
| Name | Affiliation | Role |
|---|---|---|
| Madeline A Michel, MD | Jules Bordet Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Exploration of Repeatability Coefficients in different pelvic organs, providing insights into the variability of repeatability across distinct anatomical structures. |
| Day 1 and Day 10-17 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |