Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (CArdiag)
Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
About this trial
This is an interventional diagnostic trial for Cardiac Amyloidosis focused on measuring AL Amyloidosis, ATTR Amyloidosis, Cardiac Amyloidosis
Eligibility Criteria
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 assessment is 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 in absence of other known cause of left ventricular hypertrophy (LVH),
- NT-proBNP >335 ng/L
- 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 must commit to use of a highly effective contraceptive measure for at least one week following the PET scan
- Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan
- Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan
Exclusion Criteria:
- Any known allergic reactions or hypersensitivity towards any compound of the study drug
- Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
- Inability to lay flat for up to 60 min
- Pregnant, lactating or breastfeeding
- Unwilling and/or unable to cooperate with study procedures
- Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
Sites / Locations
- Clínica Universidad de NavarraRecruiting
Arms of the Study
Arm 1
Experimental
Patients with suspected cardiac amyloidosis
After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.