Pancreas Cancer Surveillance Using an Abbreviated MRI

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04592393

Collaborator

National Research Foundation of Korea (Other)

200

Enrollment

Location

Arm

86.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Diagnostic Test: Abbreviated PB MRI Genetic: Gene mutation test Diagnostic Test: Conventional follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Oct 28, 2020

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Detection of pancreas cancer [1 year after the last surveillance MRI.]
number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.

Secondary Outcome Measures

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

Other Outcome Measures

Comparison of performance of abbreviated PB MRI [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)
Identification of super-high risk group of developing pancreas cancer [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital
National Research Foundation of Korea

Investigators

Principal Investigator: Jeong Min Lee, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04592393

Other Study ID Numbers:

SNUH-2020-2950

First Posted:

Oct 19, 2020

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital

pancreas cancer

intraductal papillary mucinous neoplasm

magnetic resonance imaging

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Mar 17, 2021