Pancreas Cancer Surveillance Using an Abbreviated MRI

Not Applicable

Active, not recruiting

• Conditions: Pancreas Cancer
• Interventions: Diagnostic Test: Abbreviated PB MRI; Genetic: Gene mutation test; Diagnostic Test: Conventional follow-up

• Registration Number: NCT04592393
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2020-10-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abbreviated PB MRI	Conventional follow-up	Short and Focused non-contrast MRI for surveillance
Abbreviated PB MRI	Gene mutation test	Short and Focused non-contrast MRI for surveillance
Abbreviated PB MRI	Abbreviated PB MRI	Short and Focused non-contrast MRI for surveillance

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Estimation of pancreas cancer risk	1 year after the last surveillance MRI.	rate of developing pancreas cancer during the study period
Scan time of abbreviated PB MRI for surveillance	1 month after the first surveillance MRI.	table time, in-room time measurement for feasibility
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of