florbetaben (18F) for Cardiac amyloidosis|AL amyloidosis

Inclusion criteria

• {"criterion_text":"- Men and women aged >18 years\n- Ability to understand, sign and date the informed consent\n- 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 criteria

• {"criterion_text":"- Hypersensitivity to the active principle or any excipient listed in the paragraph 6.1 of the Summary of Product Characteristics (RCP) of Neuraceq®\n- Chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1,73 m2)\n- 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)\n- Performing a PET/CT or scintigraphic exam within 24 hours\n- Impossibility to lay flat for about 60 minutes\n- New York Heart Association (NYHA) class IV\n- 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\n- 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\n- Lack of informed consent or impossibility to complete study procedures"}

Primary endpoints

• {"endpoint_text":"- Concordance (with 95% confidence interval) of two pathways for diagnosing AL-CA in patients with a monoclonal component: the traditional (invasive) pathway and a noninvasive pathway using 18F-florbetaben PET/CT (visual evaluation).","definition_or_measurement_approach":"Measure concordance (with 95% CI) between the traditional invasive diagnostic pathway and noninvasive 18F-florbetaben PET/CT (visual evaluation) in patients with a monoclonal component."}

Secondary endpoints

• {"endpoint_text":"- Sensitivity, specificity, positive and negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard.","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, PPV, NPV) of PET/CT (visual evaluation) versus current diagnostic standard."}
• {"endpoint_text":"- Cut-off di esclusione o di conferma diagnostica di AC tipo AL dalla PET/TC con 18Fflorbetaben (analisi quantitativa) tra i pazienti con sospetto di AC e componente monoclonale;","definition_or_measurement_approach":"Determine quantitative myocardial uptake cut-offs from PET/CT with 18F-florbetaben to confirm or exclude AL-type cardiac amyloidosis compared with the standard diagnostic algorithm."}
• {"endpoint_text":"- Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables","definition_or_measurement_approach":"Assess change in myocardial 18F-florbetaben uptake over 12 months and its relationship with clinical and instrumental variables (longitudinal quantitative uptake measurements)."}
• {"endpoint_text":"- safety and tolerability of PET/CT with 18F-florbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following","definition_or_measurement_approach":"Record adverse events during the imaging procedure and in the days immediately following to assess safety and tolerability."}

Italy

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

64

Number Of Sites

7

Number Of Participants

150

Primary sponsor

Full Name

Fondazione Toscana Gabriele Monasterio

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy