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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06458725
Other study ID # B0792024000002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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