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

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

NCT ID: NCT06458725

Condition: Rectum Cancer
Pelvic Cancer

Conditions: Official terms:
Rectal Neoplasms
Pelvic Neoplasms

Conditions: Keywords:
Repeatability
Reproducibility
MR-Linac
Radiotherapy
Functional MRI

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Magnetic Resonance Imaging (MRI)
Description: - Three MRI : - two on an MR-Linac 1.5 Tesla (10 to 17 days apart) - one on a standard 1.5 Tesla MRI
Arm group label: Volunteers

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: June 13, 2024

Completion date: November 2024

Lead sponsor:
Agency: Jules Bordet Institute
Agency class: Other

Source: Jules Bordet Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06458725