drugset / Trial / NCT05184088
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
Phase 3
Completed
244 enrolled
Lantheus Holdings, Inc.
pharmtrace klinische Entwicklung GmbH · collab
NaSingle-groupOpen-labelDiagnostic
Summary
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
Timeline
- Start
- 2023-01-13
- Primary completion
- 2026-04-21
- Completion
- 2026-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 18F-Florbetaben | Diagnostic / imaging agent | 300 mbq | — |