Improve MRI Diagnosis (DIAGIRM)

February 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2016

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Villejuif, France, 94800
        • CHU Paul Brousse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Diagnostic test: MRI Image
MRI sequences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition period
Time Frame: 7 years
Average acquisition time
7 years
Apnea
Time Frame: 7 years
Proportion of patients for whom apnea was requested.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Maïté LEWIN, MD, PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2023

Primary Completion (Anticipated)

March 15, 2030

Study Completion (Anticipated)

March 15, 2030

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP220840
  • 2022-A01358-35 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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