Status:

COMPLETED

An Observational Study to Learn More About the Impact of Gadoxetate Sodium-Enhanced Magnetic Resonance Imaging (EOB-MRI) When Used to Diagnose the Spread of Cancer From the Pancreas to the Liver in Japanese People Under Real-World Conditions

Lead Sponsor:

Bayer

Conditions:

Metastatic Pancreatic Cancer

Liver Metastases

Eligibility:

All Genders

18+ years

Brief Summary

This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received the...

Eligibility Criteria

Inclusion

  • Patients having at least one confirmed diagnosis of pancreatic cancer (identified by ICD-10 diagnosis code C25.x, without a suspicious diagnosis flag) during the patient selection period
  • Patients having at least one active treatment record after the 1st confirmed diagnosis of pancreatic cancer
  • Patients 18 years of age or older at the index date
  • Patients having any recorded CE-CT or EOB-MRI or MRI without EOB record during the baseline period
  • EOB-MRI stands for enhanced liver MRI using gadoxetate sodium as the contrast agent. In this type of MRI, gadoxetate sodium is used as a contrast agent in the visualization of the liver tumor.
  • EOB-MRI group will include patients who underwent EOB-MRI during the baseline period.
  • Non-EOB-MRI group will include patients who underwent CE-CT or MRI with contrast agent other than the gadoxetate sodium during the baseline period.
  • MRI, CE-CT and contrast agents are identified by using the nine-digit Japanese receipt code specified in the separate code list

Exclusion

  • Patients with no confirmed diagnosis of pancreatic cancer (ICD-10 diagnosis code C25.x) in the below category of the disease name in the discharge summary until the 1st discharge date after the index date:
  • "ICD-10 code of disease name which input the most medical resources"
  • "ICD-10 name of disease behind hospitalization"
  • Patients with no active treatment within 3 months (90 days) from the con-firmed pancreatic cancer diagnosis date
  • Patients with no medical record in the MDV database within 1 month (30 days) from the index date

Key Trial Info

Start Date :

November 20 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 30 2024

Estimated Enrollment :

39624 Patients enrolled

Trial Details

Trial ID

NCT06106568

Start Date

November 20 2023

End Date

October 30 2024

Last Update

November 4 2024

Active Locations (1)

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1

Many locations

Multiple Locations, Japan