Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (CArdiag)
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (CArdiag)
ClinicalTrials.gov ID: NCT05184088
Sponsor: Life Molecular Imaging GmbH
Information provided by: Life Molecular Imaging GmbH (Responsible Party)
Last Update Posted: 2023-02-16
Brief 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.
Detailed Description:
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 or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement.
The diagnostic efficacy of the visual and quantitative assessments of [18F]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.
OFFICIAL TITLE
An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis
INTERVENTION / TREATMENT
Drug: [18F]florbetaben
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-01-13 |
| Primary Completion (Estimated) | 2024-06 |
| Study Completion (Estimated) | 2024-09 |
| Enrollment (Estimated) | 200 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
FBB-02-01-21
|