NCT03731819

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 3, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

November 3, 2018

Last Update Submit

May 3, 2022

Conditions

Pancreas CystIntraductal Papillary Mucinous Neoplasm

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

  • Table time of Abbreviated PB MRI

    total scan time

    1 day after PB MRI acquisition

Secondary Outcomes (4)

  • In room time of Abbreviated PB MRI

    1 day after PB MRI acquisition

  • Diagnostic confidence

    6 months after participants enrollment

  • Image quality

    6 months after participants enrollment

  • Requirement for re-examination

    6 months after participants enrollment

Study Arms (1)

Follow-up participants

EXPERIMENTAL

Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI.

Diagnostic Test: Abbreviated PB MRI

Interventions

Abbreviated PB MRIDIAGNOSTIC_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).

Follow-up participants

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Jeong Hee Yoon, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 6, 2018

Study Start

November 5, 2018

Primary Completion

November 12, 2019

Study Completion

May 4, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)