Pancreas Cancer
Conditions
Keywords
pancreas cancer, intraductal papillary mucinous neoplasm, magnetic resonance imaging
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.
Interventions
DIAGNOSTIC_TESTAbbreviated PB MRI
Annual non-contrast PB MRI.
GENETICGene mutation test
K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.
DIAGNOSTIC_TESTConventional follow-up
Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.
Sponsors
National Research Foundation of Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of pancreas cancer | 1 year after the last surveillance MRI. | number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed