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

Withdrawn

• Conditions: Cardiac amyloidosis; 10011305; 10028593

• Registration Number: NL-OMON41377
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

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

Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study will be demonstrating that PET-scintigraphy<br /><br>with 18F-florbetaben is able to image cardiac amyloidosis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is to demonstrate that patients with cardiac amyloidosis<br /><br>have cerebral amyloid deposits.</p><br>