Improve MRI Diagnosis

Not Applicable

Not yet recruiting

• Conditions: New MRI Techniques

• Registration Number: NCT05744102
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

Detailed Description

"The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:

1. The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;

2. Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence"

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Study Start: 2023-03-15
• Primary Completion: 2030-03-15
• Study Completion: 2030-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2016

Inclusion Criteria

• Adult patient
• Patient who signed a consent to participate in the study
• Affiliated patient or beneficiary of a social security scheme
• Patient having an MRI scheduled as part of their care pathway
• Absence of prohibition of participation in another research

Exclusion Criteria

• Patients under guardianship or curators
• Pregnant or breastfeeding patients
• Patients responding to a contraindication to performing an MRI
• Patient under state medical aid (AME)
• Adult patients protected by law

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Image quality	7 years	The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

Secondary Outcome Measures

Name	Time	Method
Acquisition period	7 years	Average acquisition time
Apnea	7 years	Proportion of patients for whom apnea was requested.

Trial Locations

Locations (1)

CHU Paul Brousse; 🇫🇷 Villejuif, France