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

Comprehensive Assessment of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) Measures: Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers. (PILLAR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Cancer; Rectum Cancer
• Intervention / Treatment: Device: Magnetic Resonance Imaging (MRI)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clemence Al Wardi, PhD; Phone Number: 0032 2 541 39 81; Email: clemence.alwardi@hubruxelles.be
• Study Contact Backup: Name: Madeline A Michel, MD; Phone Number: 0032 2 541 39 15; Email: madeline.michel@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Volunteers; Single arm of volunteers.	Device: Magnetic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Investigators: Principal Investigator: Madeline A Michel, MD, Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 13, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Functional MRI; Reproducibility; MR-Linac; Repeatability
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Pelvic Neoplasms
• Other Study ID Numbers: B0792024000002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No