Establishment of Abbreviated Pancreatobiliary MRI Protocol

May 3, 2022 updated by: Jeong Hee Yoon, Seoul National University Hospital

Establishment of Abbreviated Pancreatobiliary MRI Using Compressed Sensing Technique for Pancreas Cystic Neoplasm Follow-up

This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • on follow-up for pancreas intraductal mucinous neoplasm
  • OR incidentally detected pancreas cyst (equal to or larger than 1cm)
  • AND scheduled for CECT or has CECT within a months
  • AND sign informed consent

Exclusion Criteria:

  • Any absolute or relative contra-indication for contrast-enhanced MRI
  • No pancreas cystic neoplasm
  • History of pancreatectomy
  • History of any procedure for pancreatic cyst (ablation, aspiration...) in a year
  • Hemosiderosis
  • Suspicion of acute pancreatitis

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follow-up participants
Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI.
Diagnostic test: Abbreviated PB MRI
Abbreviated PB MRI which targets table time of 10 minutes. For MRI acquisition, standard dose of commercially available MR contrast agent (Gadovist, Bayer, Germany) is used on weight-based dosing (0.1mmol/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Table time of Abbreviated PB MRI
Time Frame: 1 day after PB MRI acquisition
total scan time
1 day after PB MRI acquisition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In room time of Abbreviated PB MRI
Time Frame: 1 day after PB MRI acquisition
time spent in room by participants (difference between walk-in and walk-out times)
1 day after PB MRI acquisition
Diagnostic confidence
Time Frame: 6 months after participants enrollment
subjective diagnostic confidence for pancreas cystic neoplasm on five point scale
6 months after participants enrollment
Image quality
Time Frame: 6 months after participants enrollment
overall image quality of Abbreviated PB MRI
6 months after participants enrollment
Requirement for re-examination
Time Frame: 6 months after participants enrollment
clinical need for re-examination due to suboptimal image quality
6 months after participants enrollment

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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 (Actual)

November 5, 2018

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

May 4, 2022

Study Registration Dates

First Submitted

November 3, 2018

First Submitted That Met QC Criteria

November 3, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2018-1276

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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