Clinical Trial Record

Return to Clinical Trials

Establishment of Abbreviated Pancreatobiliary MRI Protocol


2018-11-05


2019-11-12


2022-05-04


30

Study Overview

Establishment of Abbreviated Pancreatobiliary MRI Protocol

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

N/A

  • Pancreas Cyst
  • Intraductal Papillary Mucinous Neoplasm
  • DIAGNOSTIC_TEST: Abbreviated PB MRI
  • SNUH-2018-1276

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 Registration Dates Results Reporting Dates Study Record Updates

2018-11-03  

N/A  

2022-05-03  

2018-11-03  

N/A  

2022-05-05  

2018-11-06  

N/A  

2022-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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).
Primary Outcome MeasuresMeasure DescriptionTime Frame
Table time of Abbreviated PB MRItotal scan time1 day after PB MRI acquisition
Secondary Outcome MeasuresMeasure DescriptionTime Frame
In room time of Abbreviated PB MRItime spent in room by participants (difference between walk-in and walk-out times)1 day after PB MRI acquisition
Diagnostic confidencesubjective diagnostic confidence for pancreas cystic neoplasm on five point scale6 months after participants enrollment
Image qualityoverall image quality of Abbreviated PB MRI6 months after participants enrollment
Requirement for re-examinationclinical need for re-examination due to suboptimal image quality6 months after participants enrollment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

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


    • PRINCIPAL_INVESTIGATOR: Jeong Hee Yoon, MD, Seoul National University Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available