NCT06106568

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

A Retrospective Observational Study to Investigate the Clinical Impact of EOB-MRI in the Diagnosis of Liver Metastasis of Pancreatic Cancer in Japan - A Real-World Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39,624 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer. Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver. Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results. Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions. The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs. The main information that researchers will collect in this study: participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy the length of time: from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival) from the date of first treatment for pancreatic cancer until the cancer spreads of other organs from the date of diagnosis of pancreatic cancer to starting the first treatment from the date of first treatment for pancreatic cancer to starting the second treatment option treatments that the participants have received, including anti-cancer drugs, radiation, and surgery the number of hospital visits, use of healthcare facilities, and related costs. The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI. The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022. Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study. In this study, only available data from health records are collected. No visits or tests are required as part of this study.

Conditions

• Metastatic Pancreatic Cancer
• Liver Metastases
• Gadoxetate Sodium-enhanced Magnetic Resonance Imaging

Interventions

Type	Name	Description
PROCEDURE	EOB-MRI	Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan
PROCEDURE	Surgery	Retrospective analysis for pancreatic cancer patients who had a record of any surgery for the pancreatic cancer in the Medical Data Vision (MDV) database in Japan
PROCEDURE	Open-close Laparotomy	Retrospective analysis for pancreatic cancer patients who had a record of an open-close laparotomy in the Medical Data Vision (MDV) database in Japan

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2023-10-30
• Last updated: 2024-11-04

Locations

1 site across 1 country: Japan