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

Rectum Cancer Clinical Trial

— PILLAR  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458725
• Other study ID #: B0792024000002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Jules Bordet Institute
• Contact: Madeline A Michel, MD
• Phone: 0032 2 541 39 15
• Email: madeline.michel[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Cancer
• Pelvic Neoplasms
• Rectal Neoplasms
• Rectum Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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