Establishment of Abbreviated Pancreatobiliary MRI Protocol

Pancreas Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731819
• Other study ID #: SNUH-2018-1276
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: May 4, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 4, 2022
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraductal Papillary Mucinous Neoplasm
• Neoplasms
• Pancreas Cyst
• Pancreatic Cyst

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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