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Detection of cardiac amyloidosis with 18F-florbetaben PET: a proof-of-principle study

Detection of cardiac amyloidosis with 18F-florbetaben PET: a proof-of-principle study - Detection of cardiac amyloidosis with 18F-florbetaben PET

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41377
Enrollment
20
Registered
2013-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac amyloidosis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cardiac amyloidosis: 1) Defined as histological proven by biopsy of the myocardium 2) or if not proven by myocardial biopsy the patient must fulfill all of the following criteria: - Biopsy proven amyloidosis in another organ than the heart - Left ventricular hypertrophy (> 12 mm) in combination with right ventricular hypertrophy (> 5 mm). - Diastolic dysfunction and biatrial dilatation. - Monoclonal protein and bone marrow plasmaceldyscrasie or transthyretin mutation

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study will be demonstrating that PET-scintigraphy with 18F-florbetaben is able to image cardiac amyloidosis.

Secondary

MeasureTime frame
The secondary endpoint is to demonstrate that patients with cardiac amyloidosis have cerebral amyloid deposits.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)