NCT04592393

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2020Dec 2027

First Submitted

Initial submission to the registry

October 7, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

6.2 years

First QC Date

October 7, 2020

Last Update Submit

August 16, 2023

Conditions

Pancreas Cancer

Keywords

pancreas cancerintraductal papillary mucinous neoplasmmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Detection of pancreas cancer

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

    1 year after the last surveillance MRI.

Secondary Outcomes (3)

  • Scan time of abbreviated PB MRI for surveillance

    1 month after the first surveillance MRI.

  • Estimation of pancreas cancer risk

    1 year after the last surveillance MRI.

  • Detection of pancreas cancer

    1 year after the last surveillance MRI.

Other Outcomes (2)

  • Comparison of performance of abbreviated PB MRI

    1 year after the last surveillance MRI.

  • Identification of super-high risk group of developing pancreas cancer

    1 year after the last surveillance MRI.

Study Arms (1)

Abbreviated PB MRI

EXPERIMENTAL

Short and Focused non-contrast MRI for surveillance

Diagnostic Test: Abbreviated PB MRIGenetic: Gene mutation testDiagnostic Test: Conventional follow-up

Interventions

Abbreviated PB MRIDIAGNOSTIC_TEST

Annual non-contrast PB MRI.

Abbreviated PB MRI
Gene mutation testGENETIC

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

Abbreviated PB MRI
Conventional follow-upDIAGNOSTIC_TEST

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

Abbreviated PB MRI

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jeong Min Lee, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 19, 2020

Study Start

October 28, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)