Back to resultsEstablishment of Abbreviated Pancreatobiliary MRI Protocol
Primary Purpose
Pancreas Cyst, Intraductal Papillary Mucinous Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abbreviated PB MRI
Sponsored by
About this trial
This is an interventional other trial for Pancreas Cyst focused on measuring MRI
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Follow-up participants
Arm Description
Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI.
Outcomes
Primary Outcome Measures
Table time of Abbreviated PB MRI
total scan time
Secondary Outcome Measures
In room time of Abbreviated PB MRI
time spent in room by participants (difference between walk-in and walk-out times)
Diagnostic confidence
subjective diagnostic confidence for pancreas cystic neoplasm on five point scale
Image quality
overall image quality of Abbreviated PB MRI
Requirement for re-examination
clinical need for re-examination due to suboptimal image quality
Full Information
NCT ID
NCT03731819
First Posted
November 3, 2018
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03731819
Brief Title
Establishment of Abbreviated Pancreatobiliary MRI Protocol
Official Title
Establishment of Abbreviated Pancreatobiliary MRI Using Compressed Sensing Technique for Pancreas Cystic Neoplasm Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
May 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to establish abbreviated PB MRI protocol for patients on regular imaging follow-up for pancreas cystic neoplasm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cyst, Intraductal Papillary Mucinous Neoplasm
Keywords
MRI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follow-up participants
Arm Type
Experimental
Arm Description
Patients who met eligibility criteria. Participants are going to undergo Abbreviated PB MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abbreviated PB MRI
Intervention Description
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 Measure Information:
Title
Table time of Abbreviated PB MRI
Description
total scan time
Time Frame
1 day after PB MRI acquisition
Secondary Outcome Measure Information:
Title
In room time of Abbreviated PB MRI
Description
time spent in room by participants (difference between walk-in and walk-out times)
Time Frame
1 day after PB MRI acquisition
Title
Diagnostic confidence
Description
subjective diagnostic confidence for pancreas cystic neoplasm on five point scale
Time Frame
6 months after participants enrollment
Title
Image quality
Description
overall image quality of Abbreviated PB MRI
Time Frame
6 months after participants enrollment
Title
Requirement for re-examination
Description
clinical need for re-examination due to suboptimal image quality
Time Frame
6 months after participants enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hee Yoon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Establishment of Abbreviated Pancreatobiliary MRI Protocol
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