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Clinical Trials/NCT04592393
NCT04592393
Active, not recruiting
Not Applicable

Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study

Seoul National University Hospital1 site in 1 country200 target enrollmentOctober 28, 2020
ConditionsPancreas Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Cancer
Sponsor
Seoul National University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Detection of pancreas cancer
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2020
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Detection of pancreas cancer

Time Frame: 1 year after the last surveillance MRI.

number of detected pancreas cancer (resectable \& BRPC only) in surveillance MRI.

Secondary Outcomes

  • Estimation of pancreas cancer risk(1 year after the last surveillance MRI.)
  • Scan time of abbreviated PB MRI for surveillance(1 month after the first surveillance MRI.)
  • Detection of pancreas cancer(1 year after the last surveillance MRI.)

Study Sites (1)

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