for diagnostic purposes (to assess indeterminate kidney lesions), Ultrasound contrast agent
Conditions
Brief summary
The occurrence of adverse reactions until 7±2days post injection, 12-lead ECG, Vital signs, Clinical laboratory parameters (haematology; renal and hepatic functions)
Detailed description
Parametric imaging (Time to Peak (s), Peak Enhance-ment (dB)), Parametric imaging (Wash-in Area Under the Curve (dB), Wash-out Area Under the Curve (dB)), Parametric imaging (Peak Enhancement (dB)), CEUS at 30minutes post dose is to confirm total clearing of HarMono-T
Interventions
DRUGHarMono-T 5 microlitres/mL gas and solvent for dispersion for injection/infusion
Sponsors
Solstice Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse reactions until 7±2days post injection, 12-lead ECG, Vital signs, Clinical laboratory parameters (haematology; renal and hepatic functions) | — |
Secondary
| Measure | Time frame |
|---|---|
| Parametric imaging (Time to Peak (s), Peak Enhance-ment (dB)), Parametric imaging (Wash-in Area Under the Curve (dB), Wash-out Area Under the Curve (dB)), Parametric imaging (Peak Enhancement (dB)), CEUS at 30minutes post dose is to confirm total clearing of HarMono-T | — |
Countries
Germany
Outcome results
None listed