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

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.

Study Overview

• Status: Completed
• Conditions: Liver Metastases; Metastatic Pancreatic Cancer; Gadoxetate Sodium-enhanced Magnetic Resonance Imaging
• Intervention / Treatment: Procedure: EOB-MRI; Procedure: Surgery; Procedure: Open-close Laparotomy

• Study Type: Observational
• Enrollment (Actual): 39624

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective observational study utilizing data extracted from a hospital-based administrative health insurance claims database provided by Medical Data Vision Co. Ltd (MDV, Tokyo, Japan). Eligible patients are adult patients with a confirmed diagnosis of pancreatic cancer (identified by International Classification of Diseases, 10th revision [ICD-10] code C25.x) during the overall study period (i.e., between 01 Jan 2011 and 31 Oct 2022) .

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EOB-MRI; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI	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
non-EOB-MRI; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MBI
EOB-MRI with surgery; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and surgery	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
non-EOB-MRI with surgery; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of surgery	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
EOB-MRI without surgery; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI but without a record of surgery	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
non-EOB-MRI without surgery; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI or surgery
EOB-MRI with an open-close laparotomy; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and an open-close laparotomy	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: 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
non-EOB-MRI with an open-close laparotomy; Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of an open-close laparotomy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group	Up to 12 years
Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI group	Up to 12 years
Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI group	Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group	Up to 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group within the subgroups of interest	Subgroups: with a record of surgery; without a record of surgery; with a record of an open-close laparotomy	Up to 12 years
Descriptive summary of clinical outcomes in EOB-MRI and non-EOB-MRI group within the subgroups of interest	Subgroups: with a record of surgery; without a record of surgery; with a record of an open-close laparotomy	Up to 12 years
Descriptive summary of healthcare utilization pattern in EOB-MRI and non-EOB-MRI group within the subgroups of interest	Subgroups: with a record of surgery; without a record of surgery; with a record of an open-close laparotomy	Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group within the subgroups of interest	Subgroups: with a record of surgery; without a record of surgery; with a record of an open-close laparotomy	Up to 12 years
Comparison of overall survival (time from pancreatic cancer diagnosis date to death) (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)		Up to 12 years
Comparison of time to diagnosis of new metastases from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)		Up to 12 years
Comparison of time to first treatment pathway option from the pancreatic cancer diagnosis date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)		Up to 12 years
Comparison of time to second treatment pathway option from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)		Up to 12 years
Descriptive summary of patient characteristics across three index-year groups	The study period will be divided into index year groups defined as below: Group 1: 2011-2012; Group 2: 2013-2018; Group 3: 2019-2021	Up to 12 years
Descriptive summary of clinical outcomes across three index-year groups	The study period will be divided into index year groups defined as below: Group 1: 2011-2012; Group 2: 2013-2018; Group 3: 2019-2021	Up to 12 years
Descriptive summary of treatment pathways across three index-year groups	The study period will be divided into index year groups defined as below: Group 1: 2011-2012; Group 2: 2013-2018; Group 3: 2019-2021	Up to 12 years
Descriptive summary of healthcare utilization pattern across three index-year groups	The study period will be divided into index year groups defined as below: Group 1: 2011-2012; Group 2: 2013-2018; Group 3: 2019-2021	Up to 12 years
Descriptive summary of healthcare costs across three index-year groups	The study period will be divided into index year groups defined as below: Group 1: 2011-2012; Group 2: 2013-2018; Group 3: 2019-2021	Up to 12 years
Descriptive summary of the likelihood of open-close laparotomy in patients with confirmed diagnosis of pancreatic cancer who is intended the surgical intervention between those in the EOB-MRI group and non-EOB-MRI group		Up to 12 years

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Pancreatic Neoplasms
• Other Study ID Numbers: 22470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No