Back to resultsPancreas Cancer Surveillance Using an Abbreviated MRI
Primary Purpose
Pancreas Cancer
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abbreviated PB MRI
Gene mutation test
Conventional follow-up
Sponsored by
About this trial
This is an interventional screening trial for Pancreas Cancer focused on measuring pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging
Eligibility Criteria
Inclusion Criteria:
- On follow-up due to first degree-family history of PAC
- Or on follow-up for BD-IPMN (>= 2 cm) or main-duct type IPMN (> 5 mm)
- And signed informed consent
Exclusion Criteria:
- Contra-indication of performing MRI
- Not satisfying the selection criteria.
- Previously diagnosed with pancreatic malignancy
- Pregnancy or planning pregnancy
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abbreviated PB MRI
Arm Description
Short and Focused non-contrast MRI for surveillance
Outcomes
Primary Outcome Measures
Detection of pancreas cancer
number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.
Secondary Outcome Measures
Scan time of abbreviated PB MRI for surveillance
table time, in-room time measurement for feasibility
Estimation of pancreas cancer risk
rate of developing pancreas cancer during the study period
Detection of pancreas cancer
number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.
Full Information
NCT ID
NCT04592393
First Posted
October 7, 2020
Last Updated
August 16, 2023
Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04592393
Brief Title
Pancreas Cancer Surveillance Using an Abbreviated MRI
Official Title
Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
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 a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abbreviated PB MRI
Arm Type
Experimental
Arm Description
Short and Focused non-contrast MRI for surveillance
Intervention Type
Diagnostic Test
Intervention Name(s)
Abbreviated PB MRI
Intervention Description
Annual non-contrast PB MRI.
Intervention Type
Genetic
Intervention Name(s)
Gene mutation test
Intervention Description
K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional follow-up
Intervention Description
Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.
Primary Outcome Measure Information:
Title
Detection of pancreas cancer
Description
number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.
Time Frame
1 year after the last surveillance MRI.
Secondary Outcome Measure Information:
Title
Scan time of abbreviated PB MRI for surveillance
Description
table time, in-room time measurement for feasibility
Time Frame
1 month after the first surveillance MRI.
Title
Estimation of pancreas cancer risk
Description
rate of developing pancreas cancer during the study period
Time Frame
1 year after the last surveillance MRI.
Title
Detection of pancreas cancer
Description
number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.
Time Frame
1 year after the last surveillance MRI.
Other Pre-specified Outcome Measures:
Title
Comparison of performance of abbreviated PB MRI
Description
comparison of the rates of pancreas cancer detection between abbreviated MRI and conventional follow-up methods (in available cases)
Time Frame
1 year after the last surveillance MRI.
Title
Identification of super-high risk group of developing pancreas cancer
Description
Identification of any common radiologic features and gene mutation in participants in whom pancreas cancer develop during the study period.
Time Frame
1 year after the last surveillance MRI.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On follow-up due to first degree-family history of PAC
Or on follow-up for BD-IPMN (>= 2 cm) or main-duct type IPMN (> 5 mm)
And signed informed consent
Exclusion Criteria:
Contra-indication of performing MRI
Not satisfying the selection criteria.
Previously diagnosed with pancreatic malignancy
Pregnancy or planning pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Professor
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
Pancreas Cancer Surveillance Using an Abbreviated MRI
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