- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03533855
Quality of Image and Performance Diagnoses of the 3D Sequence of Cholangio-pancreatography MRI in Apnea With Compressed Acquisition
The sequence of 3D CP-IRM, used in current practice in the protocols of bilio-pancreatic imaging, can be thus optimized to reduce acquisition time, thus the artefacts of movement, in particular in 3T. It remains however to estimate if the quality of obtained image is equivalent at least to that of the conventional sequence, without apnea, 3D CP-IRM.
To summarize, the investigators suggest comparing the classic sequence (Fast Relaxation Fast Spin Echo (FRFSE) 3D) already existing with the same sequence to which will be added a technique of CS allowing its acquisition at shortened time(weather), with respiratory trigger on one hand and in apnea on the other hand. For the patient, this study will have for consequence only the addition of 2 sequence MRI, one of the 2 minutes 30 seconds (with respiratory trigger) and other one of the 20 seconds (in apnea).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile-de-France
-
Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age> 18
- french understanding and speaking patient
- Pancreatic MRI prescription for bilio-pancreatic pathology
- Patient with medical insurance
Exclusion Criteria:
- previous biliary surgery
- MRI contraindication
- Gadolinium recently injected (48 hours)
- Patient couldn't stay on apnea 20 seconds
Study Plan
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 |
|---|---|
|
Experimental: "CS plus FRFSE
we perform a classic Fast Relaxation Fast Spin Echo (FRFSE) 3D MRI and add compressed sensing" sequence
|
we perform a classic Fast Relaxation Fast Spin Echo (FRFSE) 3D MRI and add compressed sensing" sequence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
image quality scale
Time Frame: Day 1
|
Two senior radiologists will analyse the images of MRI with CS sequence
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3D CP IRM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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