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Pancreas Cancer Surveillance Using an Abbreviated MRI


2020-10-28


2026-12-31


2027-12-31


200

Study Overview

Pancreas Cancer Surveillance Using an Abbreviated MRI

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.

N/A

  • Pancreas Cancer
  • DIAGNOSTIC_TEST: Abbreviated PB MRI
  • GENETIC: Gene mutation test
  • DIAGNOSTIC_TEST: Conventional follow-up
  • SNUH-2020-2950

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-10-07  

N/A  

2023-08-16  

2020-10-16  

N/A  

2023-08-18  

2020-10-19  

N/A  

2023-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Abbreviated PB MRI

Short and Focused non-contrast MRI for surveillance

DIAGNOSTIC_TEST: Abbreviated PB MRI

  • Annual non-contrast PB MRI.

GENETIC: Gene mutation test

  • K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.

DIAGNOSTIC_TEST: Conventional follow-up

  • Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Detection of pancreas cancernumber of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.1 year after the last surveillance MRI.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Scan time of abbreviated PB MRI for surveillancetable time, in-room time measurement for feasibility1 month after the first surveillance MRI.
Estimation of pancreas cancer riskrate of developing pancreas cancer during the study period1 year after the last surveillance MRI.
Detection of pancreas cancernumber of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.1 year after the last surveillance MRI.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Research Foundation of Korea

  • PRINCIPAL_INVESTIGATOR: Jeong Min Lee, MD, Professor

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available