cardiac amyloidosis MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
Product Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE
Product Code: [NEURA
Sponsors
FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged >35 years; Ability to understand, sign and date the informed consent; One or more of the following elements in a clinical setting deemed compatible with CA by expert clinicians: left ventricular hypertrophy (interventricular septum or posterior wall >12 mm on echocardiogram or cardiac magnetic resonance), heart failure symptoms, chronic elevation of troponin above the upper reference limit or BNP >50 ng/L or NT-proBNP >125 ng/L, low QRS voltages (particularly when coupled with left ventricular hypertrophy), circumferential subendocardial or diffuse LGE pattern, difficult myocardial nulling, early darkening of the left ventricular cavity, known plasma cell disorder (monoclonal gammopathy of unknown significance, multiple myeloma, extracardiac AL amyloidosis). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active principle or any excipient listed in the paragraph 6.1 of the Summary of Product Characteristics (RCP) of Neuraceq®; Severe chronic kidney disease [estimated glomerular filtration rate 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) or bilirubin (normal range: 1,2 mg/dL)]; Performing a PET/CT or scintigraphic exam within 24 hours; Impossibility to lay flat for about 60 minutes; New York Heart Association (NYHA) class IV; 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; 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; Lack of informed consent or impossibility to complete study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the positive predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard, in patients with a monoclonal protein;Secondary Objective: To define the diagnostic performance of PET/CT with 18Fflorbetaben (visual evaluation) in terms of sensitivity, specificity, negative predictive value; To define cut-offs from myocardial uptake quantification to confirm or discard AL-CA among patients with suspected CA and a monoclonal protein, compared to the standard diagnostic algorithm, from quantitative uptake values; To assess the changes in the degree of myocardial 18Fflorbetaben uptake over 12 months in patients with AL-CA; To assess the safety and tolerability of PET/CT with 18Fflorbetaben in patients evaluated for suspected CA.;Primary end point(s): Positive predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard.;Timepoint(s) of evaluation of this end point: Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sensitivity, specificity, negative predictive value of PET/CT with 18Fflorbetaben (visual evaluation) to diagnose AL-CA compared with the current diagnostic standard.; Cut-off of exclusion or diagnostic confirmation of AC type AL from PET / CT with 18F-florbetaben (quantitative analysis) among patients with suspected AC and monoclonal component;; Variation in the intensity of myocardial uptake of 18F-florbetaben over 12 months in relation to clinical and instrumental variables;; safety and tolerability of PET/CT with 18Fflorbetaben in patients in patients with a monoclonal component, assessed in terms of adverse events during the imaging procedure and in the days immediately following.;Timepoint(s) of evaluation of this end point: Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination); Visit 1 (The endpoint evaluation is concomitant with the PET/CT examination); Visit 4 (12 months after visit 1); Visit 2 (4 days after first administration of the IMP at visit 1) | — |
Countries
Italy
Contacts
Public ContactU.O.C. Farmacia Ospedaliera
Fondazione Toscana Gabriele Monasterio
Outcome results
None listed