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 | Completed

• 1 other identifier: 22072
• Study Type: observational
• Target: 1,602
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Overall total wastage in milliliter (mL) for single-dose vials consumed in the single-dose vial cohort

  Wastage will be defined as: For single-dose vials, any unused product that remains immediately following the administration of Gadavist to a single patient.

  Up to 12 weeks

• Overall total wastage in mL for IBPs and single-dose vials consumed in the IBP cohort

  Wastage will be defined as: For IBPs, any unused product that remains after the administration of Gadavist to some number of patients and where the allowable 24-hour window has expired, or in the event of office closure, would expire before the next scheduled Gadavist-enhanced MRI. Should a patient receive Gadavist via a single-dose vial due to insufficient product remaining in an IBP during the IBP cohort, the wastage from this single-dose vial will contribute to the overall wastage of that IBP.

  Up to 12 weeks

Secondary Outcomes (4)

• The cost associated with discarded Gadavist using the total volume of wastage for single-dose vials and IBPs cohort

  Up to 12 weeks

• The accuracy of the Bayer Radiology IBP cost calculator by comparing the estimated cost associated with discarded Gadavist as generated from the study analysis with the cost generated by the cost calculator

  Up to 12 weeks

• The average number of Gadavist administrations from each of the IBP volumes as assessed by administration counts recorded for each IBP vial sizes

  Up to 12 weeks

• The average dose of Gadavist administered from each of the IBP vial sizes as assessed by doses recorded for each IBP vial sizes

  Up to 12 weeks

Study Arms (2)

Gadavist Single-dose vial

Data will be collected from contrast-enhanced Magnetic Resonance Imaging (MRI) using Gadavist from a single-dose vial of 7.5 or 10 or 15 milliliters (mL).

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Gadavist IBP

Data will be collected from contrast-enhanced MRI using Gadavist from an IBP of either 30 or 65 milliliters (mL), and from Gadavist via a single-dose vial due to insufficient product remaining in an IBP during the IBP cohort.

Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadavist/Gadovist, BAY86-4875) DRUG

At discretion of attending physician

Gadavist IBP; Gadavist Single-dose vial

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all contrast-enhanced non-emergency Magnetic Resonance Imaging (MRI) using Gadavist for any indication at the participating site during the study period.

You may qualify if:

• A contrast-enhanced MRI using Gadavist for any indication at the study site during the study period
• Scheduled MRI to be performed in a study-designated room

You may not qualify if:

• Administration of Gadavist from a single-dose prefilled syringe
• MRIs performed in the emergency setting

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15206, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Links

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

MeSH Terms

Interventions

gadobutrol

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: November 3, 2022
• Primary Completion: March 28, 2023
• Study Completion: April 27, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)