The aim of this *proof-of-principle* study is to demonstrate that 18F-florbetaben PET can detect amyloid deposition in the myocardium in patients with proven cardiac amyloidosis and excluded amyloid deposition in the myocardium of healthy subjects.…
ID
Source
Brief title
Condition
- Myocardial disorders
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study will be demonstrating that PET-scintigraphy
with 18F-florbetaben is able to image cardiac amyloidosis.
Secondary outcome
The secondary endpoint is to demonstrate that patients with cardiac amyloidosis
have cerebral amyloid deposits.
Background summary
Cardiac amyloidosis is a diagnostic challenge. In patients with suspected
cardiac amyloidosis and with a non-cardiac biopsy showing amyloid deposition,
cardiac involvement has been defined by a consensus opinion from the 10th
International Symposium on Amyloidosis as either a positive endomyocardial
biopsy and/or increased left ventricular wall thickness in the absence of
hypertension or other potential causes of true left ventricular hypertrophy.
However, the gold standard remains a endomyocardial biopsy showing a positive
Congo red-staining with characteristic green birefringence in polarized light.
In two retrospective studies, 40 of 41 patients had a positive myocardial
biopsy, suggesting that myocardial biopsy is highly sensitive in properly
selected patients. Sensitivity of rectal biopsy in one series of 193 patients
was 84 percent. The sensitivity of kidney, liver, and carpal-tunnel biopsies
were all 90 percent or more in the same cohort. However, the sensitivity of
non-target organ biopsies, for example subcutaneous fat is only 75 to 88% in
patients with systemic amyloidosis. The risk of haemorrhage after biopsy of a
clinically affected tissue, such as renal biopsy, is 1-2%. Myocardial biopsy
should be done in experienced centres, but even then it can give complications
like perforation or bleeding. On the other hand, early recognition of the
severity of cardiac amyloidosis is important to determine the prognosis and
thus to make decisions concerning ICD implantation or heart transplantation.
Therefore, reliable early non-invasive detection of cardiac involvement is
invaluable.
With the development of a new PET tracer, 18F-florbetaben, it may be possible
to assess amyloidosis with PET.
Study objective
The aim of this *proof-of-principle* study is to demonstrate that
18F-florbetaben PET can detect amyloid deposition in the myocardium in patients
with proven cardiac amyloidosis and excluded amyloid deposition in the
myocardium of healthy subjects. Secondly, we want to study whether patients
suffering from cardiac amyloidosis have an increased amyloid load detectable in
the brain.
Study design
This is a non-randomized, single centre, observational study.
Study burden and risks
The amount of radioactivity that the participants are administered is within
the international limits set for his subjects. It should be noted that a
subject not often than once a year may be exposed to a radiation dose.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40225.018.12 |