Clinical trial NCT05350189: 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
Official title: GUS: Gadavist Drug Utilization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Enhancement in Magnetic Resonance Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 1602
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall total wastage in milliliter (mL) for single-dose vials consumed in the single-dose vial cohort
timeFrame: Up to 12 weeks
measure: Overall total wastage in mL for IBPs and single-dose vials consumed in the IBP cohort
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: The cost associated with discarded Gadavist using the total volume of wastage for single-dose vials and IBPs cohort
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
measure: The average number of Gadavist administrations from each of the IBP volumes as assessed by administration counts recorded for each IBP vial sizes
timeFrame: Up to 12 weeks
measure: The average dose of Gadavist administered from each of the IBP vial sizes as assessed by doses recorded for each IBP vial sizes
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
References: