Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (NCT05184088) | Clinical Trial Compass
RecruitingPhase 3
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
United States, Germany200 participantsStarted 2023-01-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and females age ≥18 years
* Able to understand, sign and date written informed consent
* Written informed consent must be obtained before any study procedures are performed
* Subjects being considered for a possible diagnosis of cardiac amyloidosis by
* 1\. One of the following conditions:
* Established systemic amyloidosis without proven cardiac involvement,
* Known plasma cell dyscrasia (MGUS, multiple myeloma),
* Pathological free light chain levels in urine or serum,
* Presence of heart failure with preserved ejection fraction
* 2\. AND one of the following parameters, indicative of cardiac manifestation:
* Mean (left ventricular (LV) wall + septum) thickness \>12mm as measured by echocardiography or CMR in absence of other known cause of left ventricular hypertrophy (LVH),
* NT-proBNP \>335 ng/L (in case a value for NT-proBNP is not available, BNP \> 81ng/L may be used instead)
* Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy)
* Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they mu…
What they're measuring
1
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.