Trials Sponsors Conditions Drugs Pricing

Conditions

cardiac amyloidosis

Outcome Measures

Primary Outcomes (1)

Quantification by PET parameters of myocardial uptake of the tracer in patients with cardiac amyloidosis ATTRwt, ATTRv and AL.

Secondary Outcomes (4)

Quantification of myocardial uptake of the tracer in patients with ATTRv, in patients with ATTRwt, in patients with AL and in control subjects
Quantitative differentiation of myocardial tracer uptake in patients with different ATTRv genotypes
Quantification of myocardial uptake of the tracer in patients with ATTR and weakly positive or negative scintigraphy (Perugini 0–1)
Identification and quantification of any areas of systemic uptake of the radiopharmaceutical referred to the presence of amyloid deposits (systemic amyloidosis)

Interventions

VIZAMYL 400 MBq/mL solution for injectionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
VIZAMYL 400 MBq/mL solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

VIZAMYL 400 MBq/mL solution for injection
Named ingredient: Flutemetamol (18f)
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with cardiac amyloidosis: male and female, age greater or equal 18 years diagnosed with cardiac amyloidosis. In accordance with the recommendations of the European Society of Cardiology, all of the following conditions must be present: - clinical suspicion of disease based on one or more of the following exams: cardiac examination, biomarker assay (NT-proBNP, HS-TnT, plasma protein electrophoresis, serum and urinary immunofixation, free light chains), baseline EKG, baseline echocardiography, cardiac magnetic resonance; - clearly positive osteophilic radiopharmaceutical scintigraphy (Perugini 2-3) in the absence of serum and/or urinary monoclonal component OR abdominal fat biopsy and/or endomyocardial biopsy showing ATTR or AL amyloidosis; - genetic characterization to identify patients with ATTRv; - ability to provide consent to the study.

Sponsors & Collaborators

Fondazione Toscana Gabriele Monasterio
Otherlead

Study Sites (1)

Fondazione Toscana Gabriele Monasterio

Pisa, 56124, Italy

Dario Genovesi0585493507 farmacisti@ftgm.it

Central Study Contacts

Stefania Biagini

0585493507 farmacisti@ftgm.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

October 3, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-517971-19-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:47:53 UTC

Documents

D1_PULSAR Protocol 2024-517971-19-00 v2 20230327

You may not qualify if:

pregnancy confirmed by plasma beta-HCG on 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 samesex 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 at baseline through the measurement of beta human gonadotropin on the serum;
breastfeeding;
known ischemic heart disease;
hypersensitivity to the active substance or to any of the excipients listed in the chapter 6.1 of the simplified IMPD;
severe hepatic insufficiency [alteration in the presence of known chronic liver disease of AST (male normal range> 34 IU / L; female <30 IU / L), ALT (male normal range 10-40 IU / L; female 7-35 IU / L), gamma-GT (normal range 7-64 IU / L), albumin (normal range 3.5-5 g / dl), prothrombin activity (normal range PT 70-120%) and bilirubin (normal range> 1,2 mg/dl)];
severe renal insufficiency [GFR estimated from creatinine and BUN <30 mL/ min/1.73 m2]; PET/CT or scintigraphic examination 24 hours prior to enrolment;
participation in a clinical study with an investigational drug administered within 30 days before the screening or 5 half-lives of the study drug, whichever the longest

Prospective, monocentric, exploratory phase II study for the evaluation of the diagnostic use of the tracer PET (18F) -Flutemetamol (Vizamyl®) in patients with cardiac amyloidosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations