A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography (PET-CT) to non-invasively diagnose cardiac AL amyloidosis: the PETAL study.

Trial details

Who runs it

Fondazione Toscana Gabriele Monasterio

Trial code

EU 2024-517942-33-03

Record updated

2025. január 21.

Original description

To define the concordance (with 95% confidence interval) of two pathways for the diagnosis of AL-CA in patients with a monoclonal component: the traditional (invasive) pathway and a non-invasive pathway using PET/CT with 18F-florbetaben ( visual assessment)Read full original descriptionShow less

To define the concordance (with 95% confidence interval) of two pathways for the diagnosis of AL-CA in patients with a monoclonal component: the traditional (invasive) pathway and a non-invasive pathway using PET/CT with 18F-florbetaben ( visual assessment)

Inclusion: Men and women aged >18 years; Ability to understand, sign and date the informed consent; NT-proBNP values >332 ng/L in the absence of renal insufficiency or atrial fibrillation or left ventricular mean wall thickness >12 mm on echocardiogram and/or a pattern of circumferential or diffuse subendocardial late gadolinium enhancement and/or BNP >81 ng/L, in a clinical setting judged compatible with CA by experienced clinicians.

Exclusion: Participation to a study involving the administration of an experimental drug within 30 days from the screening or 5 half-lives of the study drug, whichever the longest; Hypersensitivity to the active principle or any excipient listed in the paragraph 6.1 of the Summary of Product Characteristics (RCP) of Neuraceq®; Chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1,73 m2); New York Heart Association (NYHA) class IV; Liver disease [elevation >2 times above the upper reference limit of AST (normal range: males 34 UI/L, females 30 UI/ L), ALT (normal range: males 40 UI/L, females 35 UI/L), gamma-GT (normal range: 64 UI/L); Pregnancy or breastfeeding, women with childbearing potential and sexually active not employing highly effective contraceptive methods with a low dependency on the user (from the screening to the end of visit 1), which include: i. abstinence, ii. sexual intercourse only with same-sex partners, iii. monogamous relationship with a partner with prior vasectomy, iv. intrauterine device, v. combined hormonal contraception including estrogens and progesteron-like hormones plus the inhibition of ovulation (oral, intravaginal or transdermal), vi. hormonal contraception based on progesterone- like compounds plus the inhibition of ovulation (oral, injectable, implantable), viii. intrauterine device with hormone release. The highly effective contraceptive measures above are not required for women made sterile by surgical means (for example through tube ligation, hysterectomy, bilateral salpingectomy, bilateral ovariectomy) or after the menopause, defined as 12 months of spontaneous amenorrhea without another clinical cause and with elevated FSH levels in agreement with the expected values for the menopause. For patients with true abstinence or with just same-sex partners, contraception is not required, as far as this is in line with their preferred and habitual lifestyle. Periodical abstinence (for example, estimate of the timing of ovulation or assessment of body temperature) and coitus interruptus are not acceptable contraceptive methods. If a patient stops to be abstinent, she must use the highly effective contraceptive methods above. The pregnancy status in women potentially fertile will be checked through the measurement of beta human gonadotropin on the serum and repeated at the end of the study; Performing a PET/CT or scintigraphic exam within 24 hours; Impossibility to lay flat for about 60 minutes; Lack of informed consent or impossibility to complete study procedures.

EU CTIS 2024-517942-33-03