Pancreas Cancer Surveillance Using an Abbreviated MRI

August 16, 2023 updated by: Jeong Min Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of pancreas cancer
Time Frame: 1 year after the last surveillance MRI.
number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.
1 year after the last surveillance MRI.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month after the first surveillance MRI.
Estimation of pancreas cancer risk
Time Frame: 1 year after the last surveillance MRI.
rate of developing pancreas cancer during the study period
1 year after the last surveillance MRI.
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.
1 year after the last surveillance MRI.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of performance of abbreviated PB MRI
Time Frame: 1 year after the last surveillance MRI.
comparison of the rates of pancreas cancer detection between abbreviated MRI and conventional follow-up methods (in available cases)
1 year after the last surveillance MRI.
Identification of super-high risk group of developing pancreas cancer
Time Frame: 1 year after the last surveillance MRI.
Identification of any common radiologic features and gene mutation in participants in whom pancreas cancer develop during the study period.
1 year after the last surveillance MRI.

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

National Research Foundation of Korea

Investigators

  • Principal Investigator: Jeong Min Lee, MD, PROFESSOR

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 Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2020-2950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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