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18F-florbetaben PET-CT to Non-invasively Diagnose Cardiac AL Amyloidosis (PETAL)

Primary Purpose

Amyloid, Amyloid Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
18F-florbetaben PET/CT
Sponsored by
Fondazione Toscana Gabriele Monasterio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloid

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 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.

Sites / Locations

  • Fondazione Toscana Gabriele MonasterioRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein

Arm Description

traditional invasive approach vs. non-invasive approach using the visual assessment of 18F-florbetaben PET/TC

Outcomes

Primary Outcome Measures

Agreement between two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein

Secondary Outcome Measures

Full Information

First Posted
September 16, 2023
Last Updated
September 16, 2023
Sponsor
Fondazione Toscana Gabriele Monasterio
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1. Study Identification

Unique Protocol Identification Number
NCT06048601
Brief Title
18F-florbetaben PET-CT to Non-invasively Diagnose Cardiac AL Amyloidosis
Acronym
PETAL
Official Title
A Multi-center Phase 3 Study of 18F-florbetaben Positron Emission Tomography/Computed Tomography (PET-CT) to Non-invasively Diagnose Cardiac AL Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Toscana Gabriele Monasterio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 proteins. Cardiac involvement in amyloidosis is an important determinant of the clinical presentation and can be found in patients with amyloid light-chain (AL) or transthyretin (ATTR) amyloidosis, the latter due to the deposition of normal proteins (formerly known as senile amyloidosis) or mutated proteins. Cardiac amyloidosis (CA) has a poor prognosis that further worsens if the diagnosis and treatment are delayed. Nuclear medicine techniques have emerged as important tools for the diagnosis and characterization of CA. It has been recently demonstrated that cardiac uptake of bone tracers allows to identify the deposition of transthyretin in the heart, while it is not useful for the diagnosis of AL-CA, which currently requires the histological demonstration of amyloid fibers in a tissue sample taken with invasive procedures such as an endomyocardial biopsy. Recently, some PET tracers developed to identify beta-amyloid deposits in the brain proved able to detect an uptake even in the heart; nonetheless their possible use to diagnose CA is still debated. One of those tracers is florbetaben labelled with 18F, which displays a high binding affinity with beta-amyloid in the brain, while the experience on its use to identify extracranial amyloid deposits is still limited. Three studies have reported a cardiac uptake of 18F-florbetaben in AL or ATTR amyloidosis. Tracer uptake could be detected starting from 15 minutes after tracer administration. In a case series of 60 patients (20 with AL-CA, 20 with ATTR-CA and 20 with CA suspected but excluded) we demonstrated that the evidence of a myocardial uptake in a late acquisition can effectively discriminate AL- from ATTR-CA or other conditions. Indeed, patients with AL-CA displayed an intense and persistent myocardial uptake in static acquisitions at all time points, while patients with ATTR-CA and those without CA displayed a rapid reduction of the uptake after the early acquisition. This study aims to compare the performance of PET/CT with 18F-florbetaben to diagnose AL-CA compared with the current diagnostic standard, which requires a tissue biopsy. Primary objective: To define the agreement (with its 95% confidence interval) between two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein: the traditional invasive approach and a non-invasive approach using the visual assessment of 18F-florbetaben PET/TC. Secondary objectives: To define the diagnostic performance of PET/CT with 18F-florbetaben (visual evaluation) in terms of sensitivity, specificity, positive and 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 18F-florbetaben uptake over 12 months in patients with AL-CA; To assess the safety and tolerability of PET/CT with 18F-florbetaben in patients evaluated for suspected CA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloid, Amyloid Cardiomyopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein
Arm Type
Experimental
Arm Description
traditional invasive approach vs. non-invasive approach using the visual assessment of 18F-florbetaben PET/TC
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-florbetaben PET/CT
Intervention Description
18F-florbetaben positron emission tomography/computed tomography
Primary Outcome Measure Information:
Title
Agreement between two diagnostic approaches to the diagnosis of AL-CA in patients with a monoclonal protein
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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.
Facility Information:
Facility Name
Fondazione Toscana Gabriele Monasterio
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Emdin
Phone
+39 0503152189
Email
emdin@ftgm.it
First Name & Middle Initial & Last Name & Degree
Alberto Aimo
Phone
+39 0503152216
Email
aimoalb@ftgm.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

18F-florbetaben PET-CT to Non-invasively Diagnose Cardiac AL Amyloidosis

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