Pancreas Cancer Surveillance Using an Abbreviated MRI

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592393
• Other study ID #: SNUH-2020-2950
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of performance of abbreviated PB 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.
Other	Identification of super-high risk group of developing pancreas cancer	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.
Primary	Detection of pancreas cancer	number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI.	1 year after the last surveillance MRI.
Secondary	Scan time of abbreviated PB MRI for surveillance	table time, in-room time measurement for feasibility	1 month after the first surveillance MRI.
Secondary	Estimation of pancreas cancer risk	rate of developing pancreas cancer during the study period	1 year after the last surveillance MRI.
Secondary	Detection of pancreas cancer	number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.	1 year after the last surveillance MRI.