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Not yet recruiting NCT05744102

Improve MRI Diagnosis

No phase Interventional New MRI Techniques

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI Image.
Who it may be relevant to
Registry conditions: New MRI Techniques. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

Overview

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"

Interventions

  • Diagnostic test MRI Image
    MRI sequences

Primary outcome measures

  • Image quality [Time frame: 7 years]
Secondary outcome measures (2)
  • Acquisition period [Time frame: 7 years]
  • Apnea [Time frame: 7 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHU Paul Brousse — Villejuif

Identifiers

NCT: NCT05744102 · APHP220840 · 2022-A01358-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗