Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05744102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-01-23
Brief Title:
Improve MRI Diagnosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAGIRM
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 Cohens Kappa coefficient which must be greater than or equal to 08 When these two criteria are met the new sequence will be considered superior to 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 Cohens Kappa coefficient which must be greater than or equal to 08 When these two criteria are met the new sequence will be considered superior to the standard sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01358-35 | OTHER | IDRCB | None |