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
NCT ID: NCT06106568
Last Updated: 2024-11-04
Study Results
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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COMPLETED
39624 participants
OBSERVATIONAL
2023-11-20
2024-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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
No interventions assigned to this group
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
EOB-MRI
Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan
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
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
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
No interventions assigned to this group
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
EOB-MRI
Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan
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
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
Interventions
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EOB-MRI
Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* "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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many locations
Multiple Locations, , Japan
Countries
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Related Links
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Other Identifiers
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22470
Identifier Type: -
Identifier Source: org_study_id
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