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Clinical Trials/NCT05744102
NCT05744102
Not yet recruiting
Not Applicable

Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

Assistance Publique - Hôpitaux de Paris1 site in 1 country2,016 target enrollmentMarch 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
New MRI Techniques
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
2016
Locations
1
Primary Endpoint
Image quality
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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"

Registry
clinicaltrials.gov
Start Date
March 15, 2023
End Date
March 15, 2030
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Image quality

Time Frame: 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 Outcomes

  • Acquisition period(7 years)
  • Apnea(7 years)

Study Sites (1)

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