Contrast Enhancement in Magnetic Resonance ImagingNCT05350189
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
An observational study of Contrast Enhancement in Magnetic Resonance Imaging, run by Bayer at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Contrast Enhancement in Magnetic Resonance Imaging
- What is being tested?
- Gadobutrol (Gadavist/Gadovist, BAY86-4875)
- How many people
- 1,602 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2022to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Administration of Gadavist from a single-dose prefilled syringe
- MRIs performed in the emergency setting
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15206
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: GUS: Gadavist Drug Utilization Study
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.
Read more
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.
- Being tested
- Gadobutrol (Gadavist/Gadovist, BAY86-4875)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadavist/Gadovist, BAY86-4875)Drug
At discretion of attending physician
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start3 Nov 2022
- Primary completion28 Mar 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Enhancement in Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350189
- Sponsor's protocol ID
- 22072
- Status last verified
- Mar 2024
- First submitted
- 22 Apr 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUS: Gadavist Drug Utilization Study
- ClinicalTrials.gov ID
- NCT05350189
- Acronym / sponsor ID
- 22072
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadavist Single-dose vial | – | Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)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). |
| Gadavist IBP | – | Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Administration of Gadavist from a single-dose prefilled syringe
- MRIs performed in the emergency setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadobutrol (Gadavist/Gadovist, BAY86-4875)At discretion of attending physician | Drug | Gadavist IBP, Gadavist Single-dose vial |
Primary outcome
Overall total wastage in milliliter (mL) for single-dose vials consumed in the single-dose vial cohort
Time frame: Up to 12 weeks
Wastage will be defined as: For single-dose vials, any unused product that remains immediately following the administration of Gadavist to a single patient.
Overall total wastage in mL for IBPs and single-dose vials consumed in the IBP cohort
Time frame: Up to 12 weeks
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.
4 secondary outcomes
The cost associated with discarded Gadavist using the total volume of wastage for single-dose vials and IBPs cohort
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Contrast Enhancement in Magnetic Resonance Imaging
Recruiting
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body
Head and Neck Cancer
Not yet recruitingObservational study
Diagnostic Accuracy of Multiparametric Dynamic Contrast Enhanced Magnetic Resonance Imaging in Improving Detection of Ultrasound Non-mass Breast Lesions According to ACR BI-RADS v2025
Non Mass Breast Lesions
RecruitingPhase 2/3
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients
Known or Highly Suspected Central Nervous System (CNS) Lesion, Known or Highly Suspected Body (Excluding CNS) Lesion
Recruiting
Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial
Breast Cancer Screening and Diagnosis
Enrolling by invitationObservational study
Retrospective Multicenter Study of Patient-level T1CE/FLAIR MRI Deep Learning to Predict EGFR/ALK Driver Status in NSCLC Brain Metastases With External Validation and Survival Analysis
Non-Small Cell Lung Cancer, Brain Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Enhancement in Magnetic Resonance Imaging, run by Bayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall total wastage in milliliter (mL) for single-dose vials consumed in the single-dose vial cohort (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.