Assessment of DW-MRI Measures : Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers

Not Applicable

Not yet recruiting

• Conditions: Pelvic Cancer; Rectum Cancer
• Interventions: Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT06458725
• Lead Sponsor: Jules Bordet Institute

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study Start: 2024-06-13
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-09-01
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volunteers	Magnetic Resonance Imaging (MRI)	Single arm of volunteers.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.