Pancreas Cancer Surveillance Using an Abbreviated MRI

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2026

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Abbreviated PB MRI
    • Short and Focused non-contrast MRI for surveillance

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Scan time of abbreviated PB MRI for surveillance
    • Time Frame: 1 month after the first surveillance MRI.
    • table time, in-room time measurement for feasibility
  • Estimation of pancreas cancer risk
    • Time Frame: 1 year after the last surveillance MRI.
    • rate of developing pancreas cancer during the study period
  • Detection of pancreas cancer
    • Time Frame: 1 year after the last surveillance MRI.
    • number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • National Research Foundation of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeong Min Lee, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jeong Min Lee, MD, Principal Investigator, Professor

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