NCT03533855

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

May 11, 2018

Last Update Submit

April 26, 2023

Conditions

Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

  • image quality scale

    Two senior radiologists will analyse the images of MRI with CS sequence

    Day 1

Study Arms (1)

"CS plus FRFSE

EXPERIMENTAL

we perform a classic Fast Relaxation Fast Spin Echo (FRFSE) 3D MRI and add compressed sensing" sequence

Diagnostic Test: CS plus FRFSE

Interventions

CS plus FRFSEDIAGNOSTIC_TEST

we perform a classic Fast Relaxation Fast Spin Echo (FRFSE) 3D MRI and add compressed sensing" sequence

"CS plus FRFSE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\> 18
  • french understanding and speaking patient
  • Pancreatic MRI prescription for bilio-pancreatic pathology
  • Patient with medical insurance

You may not qualify if:

  • previous biliary surgery
  • MRI contraindication
  • Gadolinium recently injected (48 hours)
  • Patient couldn't stay on apnea 20 seconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • ZINS Marc, MD

    GHPSJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

January 3, 2018

Primary Completion

April 25, 2018

Study Completion

December 31, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

FR(1)