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NCT05350189 · ClinicalTrials.gov registry record
A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 1,602
- Enrollment target
NCT05350189: Completed study, sponsored by Bayer.
NCT05350189 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 1,602 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05350189 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 1,602 participants
- Enrollment target
Study Summary
This is an observational study, in which data associated with the wastage with the use of Gadavist single-dose vials, as compared to the wastage associated with the use of the Gadavist imaging bulk packages (IBP) used for contrast-enhanced magnetic resonance imaging (MRI) using Gadavist will be compared. MRI is a medical technique, which creates detailed images of the organs, soft tissues and structures inside the body. Combination of MRI with a "dye" that is injected into the vein (called contrast media, like Gadavist) creates what is called a contrast-enhanced MRI that enables clearer pictures of the body and helps doctors to see problems better than an MRI without contrast media. The drug Gadavist (also called gadobutrol) is a gadolinium-based contrast media for diagnostic use in MRI, which is given as an injection into the vein to improve the quality of the MRI pictures. Gadavist is already approved for several indications including imaging of brain and spinal cord, breast imaging, imaging of blood vessels, and diagnoses of heart disease. It helps doctors for example to detect: * areas with disrupted blood brain barrier (BBB), which is crucial to protect the brain from toxic components and pathogens (germs, viruses, disease-causing agents) * abnormal blood vessels in certain blood vessels * presence and size of breast cancer * heart disease The dosing of Gadavist is weight-based and currently available in single-use vials, which are associated with wastage. To reduce wastage and wastage associated costs, multi-dose vials, also called imaging bulk packages (IBP) were developed, which are already approved in the USA since January 2021. The aim of this study is to understand how much of the contrast agent Gadavist is used and how much is wasted in two different containers (single-dose vials and Imaging Bulk Packages (IBP)) in a real-world setting. To do this, researchers will review information collected regarding the amount of Gadavist used for patients underg
Primary Outcome
Wastage will be defined as: For single-dose vials, any unused product that remains immediately following the administration of Gadavist to a single patient.
Interventions
- DRUG Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,602 participants |
| Start Date | 2022-11-03 |
| Est. Completion | 2023-04-27 |
What the finished NCT05350189 record still lists
NCT05350189 is an observational study that tracks outcomes without assigning an intervention. Its 1,602 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Gadobutrol (Gadavist/Gadovist, BAY86-4875) is the first listed.
NCT05350189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05350189 about?
NCT05350189 is a clinical study titled "A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting". This is an observational study, in which data associated with the wastage with the use of Gadavist single-dose vials, as compared to the wastage associated with the use of the Gadavist imaging bulk packages (IBP) used for contrast-enhanced magnetic resonance imaging (MRI) using Gadavist will be comp...
What is the current status of trial NCT05350189?
This trial is currently completed. The enrollment target is 1,602 participants. The study started on 2022-11-03. Estimated completion is 2023-04-27.
What interventions are being tested in trial NCT05350189?
The interventions under investigation include: Gadobutrol (Gadavist/Gadovist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT05350189?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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