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| ID | Type | Description | Link |
|---|---|---|---|
| BASEC 2025-00253 | Other Identifier | Cantonal Ethics Committee Bern, Switzerland |
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The purpose of this study is to compare the effects of the contrast agent Gadopiclenol with those of the standard contrast agent Gadobutrol.
The main question of this study is :
Does gadopiclenol offer diagnostic properties that are equally effective as those of gadobutrol?
Participants will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol (control) | Active Comparator | 0.1 mmol/kg gadobutrol will be injected intravenously. |
|
| Gadopiclenol | Experimental | 0.05 mmol/kg gadopiclenol will be injected intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadovist/Gadavist) | Drug | Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadobutrol contrast injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enhancement of the kidney and adrenal tissue | The primary endpoint is the enhancement of the kidney and adrenal tissue (difference of T1, longitudinal relaxation time, of the organ signal before and after contrast agent application) in both contrast agent groups 60s and 15min after contrast injection. | 60s and 15min after contrast injection during the one and only imaging session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grazia M. Cereghetti, PhD | Contact | +41 31 632 65 80 | graziamaria.cereghetti@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Christe, Prof. Dr. med. | Bern University Hospital, Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diagnostic, Interventional and Pediatric Radiology Inselspital, University of Bern | Recruiting | Bern | 3010 | Switzerland |
The Study Protocol, including the case report form with the type of variables collected for each individual will be shared.
The Study Protocol will be made available at end of study. The availability will be open-ended.
The IPD will be available to researchers, healthcare and patients through a yet to identify platform.
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| Gadopiclenol | Drug | Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadopiclenol contrast injection. |
|
| ID | Term |
|---|---|
| C090600 | gadobutrol |
| C000656634 | gadopiclenol |
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