Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458725
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-08
Brief Title:
Assessment of DW-MRI Measures Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers
Sponsor:
Jules Bordet Institute
Organization:
Jules Bordet Institute
Study Overview
Official Title:
Comprehensive Assessment of Diffusion-Weighted Magnetic Resonance Imaging DW-MRI Measures Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers PILLAR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PILLAR
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 15 Tesla MR-Linac Unity Elekta device and an MRI on a standard 15 Tesla MRI Siemens Between days 10 to 17 they will exclusively undergo an MR-Linac 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 15 Tesla MR-Linac Unity Elekta device and an MRI on a standard 15 Tesla MRI Siemens Between days 10 to 17 they will exclusively undergo an MR-Linac session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None