check_circleStudy Completed
Metastatic pancreatic cancer, Liver metastases, Gadoxetate sodium-enhanced magnetic resonance imaging
Bayer Identifier:
22470
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
39624Trial Dates
November 2023 - October 2024Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Japan |
Primary Outcome
- Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI groupdate_rangeTime Frame:Up to 12 years
- Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI groupdate_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI groupdate_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI groupdate_rangeTime Frame:Up to 12 years
Secondary Outcome
- Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group within the subgroups of interestSubgroups: - with a record of surgery - without a record of surgery - with a record of an open-close laparotomydate_rangeTime Frame:Up to 12 years
- Descriptive summary of clinical outcomes in EOB-MRI and non-EOB-MRI group within the subgroups of interestSubgroups: - with a record of surgery - without a record of surgery - with a record of an open-close laparotomydate_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare utilization pattern in EOB-MRI and non-EOB-MRI group within the subgroups of interestSubgroups: - with a record of surgery - without a record of surgery - with a record of an open-close laparotomydate_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group within the subgroups of interestSubgroups: - with a record of surgery - without a record of surgery - with a record of an open-close laparotomydate_rangeTime Frame: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)date_rangeTime Frame: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)date_rangeTime Frame: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)date_rangeTime Frame: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)date_rangeTime Frame:Up to 12 years
- Descriptive summary of patient characteristics across three index-year groupsThe study period will be divided into index year groups defined as below: - Group 1: 2011-2012 - Group 2: 2013-2018 - Group 3: 2019-2021date_rangeTime Frame:Up to 12 years
- Descriptive summary of clinical outcomes across three index-year groupsThe study period will be divided into index year groups defined as below: - Group 1: 2011-2012 - Group 2: 2013-2018 - Group 3: 2019-2021date_rangeTime Frame:Up to 12 years
- Descriptive summary of treatment pathways across three index-year groupsThe study period will be divided into index year groups defined as below: - Group 1: 2011-2012 - Group 2: 2013-2018 - Group 3: 2019-2021date_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare utilization pattern across three index-year groupsThe study period will be divided into index year groups defined as below: - Group 1: 2011-2012 - Group 2: 2013-2018 - Group 3: 2019-2021date_rangeTime Frame:Up to 12 years
- Descriptive summary of healthcare costs across three index-year groupsThe study period will be divided into index year groups defined as below: - Group 1: 2011-2012 - Group 2: 2013-2018 - Group 3: 2019-2021date_rangeTime Frame: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 groupdate_rangeTime Frame:Up to 12 years
Trial design
Trial Type
ObservationalIntervention Type
Procedure/SurgeryTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A