Status:
UNKNOWN
18F-florbetaben PET-CT to Non-invasively Diagnose Cardiac AL Amyloidosis
Lead Sponsor:
Fondazione Toscana Gabriele Monasterio
Conditions:
Amyloid
Amyloid Cardiomyopathy
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
Amyloidoses are systemic or acquired disorders characterized by the deposition in the extracellular spaces of amyloid fibers formed by proteins codified by mutated genes or non-mutated but misfolded p...
Eligibility Criteria
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 in-sufficiency or atrial fibrillation or mean left ventricular wall thickness \>12 mm on echocardiogram and / or a pat-tern of circumferential or diffuse late gadolinium en-hancement and/or BNP \>81 ng/L, in a clinical setting seemed compatible with CA by experienced doctors.
Exclusion
- 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 filtra-tion rate \<30 mL/min/1.73 m2);
- 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 po-tential 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 part-ners, iii. monogamous relationship with a partner with pri-or vasectomy, iv. intrauterine device, v. combined hormo-nal contraception including estrogens and progesteron-like hormones plus the inhibition of ovulation (oral, intravagi-nal or transdermal), vi. hormonal contraception based on progesterone-like compounds plus the inhibition of ovula-tion (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, hys-terectomy, bilateral salpingectomy, bilateral ovariectomy) or after the menopause, defined as 12 months of spontane-ous amenorrhea without another clinical cause and with el-evated 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 gonado-tropin 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.
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06048601
Start Date
January 26 2023
End Date
January 31 2025
Last Update
September 21 2023
Active Locations (1)
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1
Fondazione Toscana Gabriele Monasterio
Pisa, Italy