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Active, Not Recruiting

NCT Number: NCT04592393

Pancreas Cancer Surveillance Using an Abbreviated MRI

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abbreviated PB MRI

Diagnostic Test

Annual non-contrast PB MRI.

Gene mutation test

Genetic

K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.

Conventional follow-up

Diagnostic Test

Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.

Primary outcomes

  1. Detection of pancreas cancer

    Time frame: 1 year after the last surveillance MRI.

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

Secondary outcomes

  1. Scan time of abbreviated PB MRI for surveillance

    Time frame: 1 month after the first surveillance MRI.

    table time, in-room time measurement for feasibility

  2. Estimation of pancreas cancer risk

    Time frame: 1 year after the last surveillance MRI.

    rate of developing pancreas cancer during the study period

  3. Detection of pancreas cancer

    Time frame: 1 year after the last surveillance MRI.

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

Other outcomes

  1. Comparison of performance of abbreviated PB MRI

    Time frame: 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)

  2. Identification of super-high risk group of developing pancreas cancer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 19, 2020
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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