DIAGIRM: Improve MRI Diagnosis

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05744102
• Collaborator: (none)
• Enrollment: 2,016
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 24

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
New MRI Techniques	Diagnostic Test: MRI Image	N/A

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
• Anticipated Enrollment: 2016 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis
• Anticipated Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Mar 15, 2030
• Anticipated Study Completion Date: Mar 15, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Image quality [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 Outcome Measures

1. Acquisition period [7 years]

   Average acquisition time

2. Apnea [7 years]

   Proportion of patients for whom apnea was requested.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Paul Brousse	Villejuif		France	94800

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05744102
• Other Study ID Numbers: APHP220840; 2022-A01358-35
• First Posted: Feb 24, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Advanced MRI

Study Results

No Results Posted as of Feb 24, 2023