Skip to main content
OpenTrials
Completed

NCT Number: NCT03731819

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreas Cyst Cysts Digestive System Diseases Intraductal Papillary Mucinous Neoplasm Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abbreviated PB MRI

Diagnostic Test

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 outcomes

  1. Table time of Abbreviated PB MRI

    Time frame: 1 day after PB MRI acquisition

    total scan time

Secondary outcomes

  1. 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)

  2. Diagnostic confidence

    Time frame: 6 months after participants enrollment

    subjective diagnostic confidence for pancreas cystic neoplasm on five point scale

  3. Image quality

    Time frame: 6 months after participants enrollment

    overall image quality of Abbreviated PB MRI

  4. Requirement for re-examination

    Time frame: 6 months after participants enrollment

    clinical need for re-examination due to suboptimal image quality

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Nov 6, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.