Improve MRI Diagnosis (DIAGIRM)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: New MRI Techniques

Treatments: Diagnostic Test: MRI Image

Study type: Interventional

Funder types: Other

Identifiers

NCT05744102

APHP220840

2022-A01358-35 (Other Identifier)

Details and patient eligibility

About

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

Full 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"

Enrollment: 2,016 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,016 participants in 1 patient group

Adult patients having MRI planned at Paul Brousse Hospital

Other group

Description:

Evaluate new MRI sequences on a population of patients undergoing MRI as part of their usual care

Treatment:

Diagnostic Test: MRI Image