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Clinical Trials/NCT05744102
NCT05744102Not yet recruitingNot Applicable

Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

Assistance Publique - Hôpitaux de Paris2 sites in 1 country2,016 target enrollmentStarted: March 15, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
2,016
Locations
2
Primary Endpoint
Image quality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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"

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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