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)
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedStudy Start
First participant enrolled
June 13, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJune 14, 2024
April 1, 2024
3 months
May 8, 2024
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Percentage of variation between the different calculation Methods for Repeatability Coefficient.
Day 1 and Day 10-17
Percentage of variation across various pelvic organs for Repeatability Coefficient.
Day 1 and Day 10-17
Other Outcomes (1)
Percentage of variation based on sequence types for the Repeatability Coefficients.
Day 1 and Day 10-17
Study Arms (1)
Volunteers
OTHERSingle arm of volunteers.
Interventions
\- Three MRI : * two on an MR-Linac 1.5 Tesla (10 to 17 days apart) * one on a standard 1.5 Tesla MRI
Eligibility Criteria
You may qualify if:
- ≥ 18 yo
- Healthy
- Volunteer
- Ability to undergo an MRI
You may not qualify if:
- \< 18yo
- Contraindication to undergoing an MRI (see safety questionnaire)
- Previous pelvic irradiation
- Pelvic pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madeline A Michel, MD
Jules Bordet Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
June 14, 2024
Study Start
June 13, 2024
Primary Completion
September 1, 2024
Study Completion
November 1, 2024
Last Updated
June 14, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share