Pancreas Cancer Surveillance Using an Abbreviated MRI

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Diagnostic Test: Abbreviated PB MRI
* Genetic: Gene mutation test
* Diagnostic Test: Conventional follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abbreviated PB MRI<br>Short and Focused non-contrast MRI for surveillance | Diagnostic Test: Abbreviated PB MRI<br>* Annual non-contrast PB MRI.<br>Genetic: Gene mutation test<br>* K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.<br>Diagnostic Test: Conventional follow-up<br>* Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of pancreas cancer | 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 | table time, in-room time measurement for feasibility | 1 month after the first surveillance MRI. | 
| Estimation of pancreas cancer risk | rate of developing pancreas cancer during the study period | 1 year after the last surveillance MRI. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging