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

Free University of Brussels (ULB)

Status: Not yet enrolling

Conditions: Pelvic Cancer; Rectum Cancer

Treatments: Device: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06458725

B0792024000002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Volunteers

Other group

Description:

Single arm of volunteers.

Treatment:

Device: Magnetic Resonance Imaging (MRI)