Improve MRI Diagnosis

NCT ID: NCT05744102

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2016 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2030-03-15

Brief Summary

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

Detailed Description

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"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"

Conditions

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New MRI Techniques

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adult patients having MRI planned at Paul Brousse Hospital

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

Group Type OTHER

MRI Image

Intervention Type DIAGNOSTIC_TEST

MRI sequences

Interventions

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MRI Image

MRI sequences

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maïté LEWIN, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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CHU Paul Brousse

Villejuif, , France

Site Status

Countries

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France

Central Contacts

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Maïté LEWIN, MD, PHD

Role: CONTACT

(33) 06 11 15 06 17

Jean-manuel DA-MOTA-FERREIRA, Radiologic Technologist

Role: CONTACT

(33) 01 45 59 35 26

Facility Contacts

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LEWIN MAITE, MD, PhD

Role: primary

00 (33) 6 11 15 06 17

Other Identifiers

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2022-A01358-35

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220840

Identifier Type: -

Identifier Source: org_study_id

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