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Active, not recruitingNCT04592393Updated Aug 18, 2023

Pancreas Cancer Surveillance Using an Abbreviated MRI

An interventional study of Abbreviated PB MRI and Gene mutation test in Pancreas Cancer, sponsored by Seoul National University Hospital. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreas Cancer

Keywords

  • pancreas cancer
  • intraductal papillary mucinous neoplasm
  • magnetic resonance imaging
03

In context

Pancreatic Neoplasms

3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.

This study's enrollment of 200 is above the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Contra-indication of performing MRI
  • Not satisfying the selection criteria.
  • Previously diagnosed with pancreatic malignancy
  • Pregnancy or planning pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Abbreviated PB MRI

    Short and Focused non-contrast MRI for surveillance

    Diagnostic Test: Abbreviated PB MRI · Genetic: Gene mutation test · Diagnostic Test: Conventional follow-up

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.

06

What researchers measure

Primary outcomes

  1. Detection of pancreas cancer

    number of detected pancreas cancer (resectable \& BRPC only) in surveillance MRI.

    Time frame: 1 year after the last surveillance MRI.

Secondary outcomes

  1. Scan time of abbreviated PB MRI for surveillance

    table time, in-room time measurement for feasibility

    Time frame: 1 month after the first surveillance MRI.

  2. Estimation of pancreas cancer risk

    rate of developing pancreas cancer during the study period

    Time frame: 1 year after the last surveillance MRI.

  3. Detection of pancreas cancer

    number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.

    Time frame: 1 year after the last surveillance MRI.

Other outcomes

  1. 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)

    Time frame: 1 year after the last surveillance MRI.

  2. 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.

    Time frame: 1 year after the last surveillance MRI.

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04592393
Lead sponsor
Seoul National University Hospital
Collaborators
National Research Foundation of Korea
Responsible party
Jeong Min Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 19, 2020
Start date
Oct 28, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 18, 2023

Study contacts

Jeong Min Lee, MD
principal investigator · Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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