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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

NCT05350189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1602

Last updated 2024-04-01

No results posted yet for this 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 undergoing contrast-enhanced MRI for any indication regarding:

* vial type (single-dose or IBP)
* size of single-dose or IBP
* volume of administered dose (mL)
* date of administration
* time of administration
* injection modality (manual vs power)
* type of power injector, if applicable

There will be no study-mandated visits or treatments. The decision to undergo a contrast-enhanced MRI with Gadavist will be made by the study participants with their doctors before data collection, and independently of this study. Data will be collected over a period of approximately 6-weeks, until the data collection of 1200 participants for each comparison group (vial type) is completed. No patient information beyond Gadavist dose will be collected in this study.

Conditions

  • Contrast Enhancement in Magnetic Resonance Imaging

Interventions

DRUG

Gadobutrol (Gadavist/Gadovist, BAY86-4875)

At discretion of attending physician

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2023-03-28
Completion
2023-04-27

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350189 on ClinicalTrials.gov