Pancreas Cancer Surveillance Using an Abbreviated MRI

NCT ID: NCT04592393

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2027-12-31

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.

Detailed Description

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Conditions

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Pancreas Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Abbreviated PB MRI

Short and Focused non-contrast MRI for surveillance

Group Type EXPERIMENTAL

Abbreviated PB MRI

Intervention Type DIAGNOSTIC_TEST

Annual non-contrast PB MRI.

Gene mutation test

Intervention Type GENETIC

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

Conventional follow-up

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Abbreviated PB MRI

Annual non-contrast PB MRI.

Intervention Type DIAGNOSTIC_TEST

Gene mutation test

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

Intervention Type GENETIC

Conventional follow-up

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2020-2950

Identifier Type: -

Identifier Source: org_study_id

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