Clinical Trials Register

Summary
EudraCT Number:	2017-001660-38
Sponsor's Protocol Code Number:	FLORAMICAR2
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-06-24
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-001660-38

A.3

Full title of the trial

A prospective triple-arm, monocentric, phase-II explorative study on evaluation of diagnostic efficacy of the PET tracer (18F)-florbetaben (Neuraceq®) in patients with cardiac amyloidosis - FLORAMICAR 2

Studio prospettico, monocentrico, esplorativo di fase II a tre bracci per la valutazione dell'efficacia diagnostica del tracciante PET (18F)-Florbetaben (Neuraceq®) in pazienti con amiloidosi cardiaca - STUDIO FLORAMICAR 2

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A prospective study on evaluation of diagnostic efficacy of the PET tracer (18F)-florbetaben (Neuraceq®) in patients with cardiac amyloidosis - FLORAMICAR 2

Studio prospettico per la valutazione dell'efficacia diagnostica del tracciante PET (18F)-Florbetaben (Neuraceq®) in pazienti con amiloidosi cardiaca - STUDIO FLORAMICAR 2

A.3.2

Name or abbreviated title of the trial where available

FLORAMICAR 2

A.4.1

Sponsor's protocol code number

FLORAMICAR2

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE TOSCANA GABRIELE MONASTERIO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FONDAZIONE TOSCANA GABRIELE MONASTERIO
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione Toscana Gabriele Monasterio
B.5.2	Functional name of contact point	U.O.C. Farmaceutica Ospedaliera
B.5.3	Address:
B.5.3.1	Street Address	via aurelia sud
B.5.3.2	Town/ city	massa
B.5.3.3	Post code	54100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0585493507
B.5.5	Fax number	0585493508
B.5.6	E-mail	farmacisti@ftgm.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
D.2.1.1.2	Name of the Marketing Authorisation holder	PIRAMAL IMAGING GMBH
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Neuraceq 300MBq/mL soluzione iniettabile
D.3.2	Product code	Neuraceq 300MBq/mL
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLORBETABEN
D.3.9.2	Current sponsor code	FLORBETABEN
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

cardiac amyloidosis

amiloidosi cardiaca

E.1.1.1

Medical condition in easily understood language

cardiac amyloidosis

amiloidosi cardiaca

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10007509
E.1.2	Term	Cardiac amyloidosis
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10007509
E.1.2	Term	Cardiac amyloidosis
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the specificity of the tracer [18F]-Florbetaben for amyloid deposits in patients with cardiac amyloidosis AL and ATTR by comparison with a control group represented by patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.

Valutare la specificità del tracciante [18F]-Florbetaben per i depositi di amiloide cardiaca in pazienti con amiloidosi AL ed ATTR mediante il confronto con un gruppo di controllo costituito da pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa.

E.2.2

Secondary objectives of the trial

1. Set modality and timing of PET/CT scans in order to obtain a differential diagnosis between the two types of cardiac amyloidosis by comparison with a control group represented by patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy;
2. Identify possible differences in regional distribution of the tracer between the two groups of patients with cardiac amyloidosis and in patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.

1. Individuare le modalità ed i tempi di acquisizione PET/CT in grado di fornire una differenziazione fra le due forme di amiloidosi cardiaca rispetto ai pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa utilizzati come gruppo di controllo.
2. Individuare eventuali differenze in termini di distribuzione regionale del radiofarmaco fra i due gruppi di pazienti con amiloidosi cardiaca.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Group of patients with cardiac amyloidosis AL and ATTR: males or females, age>20 years, patient with diagnosis of cardiac amyloidosis.
Group of patients with non-infiltrative hypertrophic cardiomyopathy: males or females, age>20 years, non-infiltrative hypertrophic cardiomyopathy.

Gruppo di pazienti con amiloidosi cardiaca AL ed ATTR: Maschi e femmine di qualsiasi etnia, Età > 20 anni, diagnosi di amiloidosi cardiaca.
Gruppo di pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa: Maschi e femmine di qualsiasi etnia, Età > 20 anni, Ipertrofia ventricolare sinistra di natura non infiltrativa

E.4

Principal exclusion criteria

Patients previously enrolled in FLORAMICAR study (EudraCT 2015-005384-16), pregnancy checked by plasma beta-HCG or breastfeeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricular hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SPC) Neuraceq®, severe renal failure, liver failure, PET / CT or scintigraphic examination 24 h before enrollment.

Pazienti già arruolati nel protocollo FLORAMICAR (EudraCT 2015-005384-16), donne in stato di gravidanza accertato mediante dosaggio plasmatico di beta-HCG o in allattamento, cardiopatia ischemica nota, cardiomiopatia ipertrofica, malattie da accumulo o altre cause note di ipertrofia o pseudoipertrofia VS, ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti elencati al paragrafo 6.1 del Riassunto delle Caratteristiche del Prodotto (RCP) di Neuraceq®, insufficienza renale severa, insufficienza epatica, esecuzione di un esame PET/CT o scintigrafico nelle 24 h precedenti l’arruolamento.

E.5 End points

E.5.1

Primary end point(s)

Qualitatively and quantitatively evaluation of myocardial uptake in patients with cardiac amyloidosis both AL and ATTR and in patients with non-infiltrative hypertrophic cardiomyopathy.

Valutare qualitativamente e quantitativamente la dinamica e l’entità della captazione miocardica del tracciante in pazienti con amiloidosi cardiaca AL ed ATTR e nei pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa.

E.5.1.1

Timepoint(s) of evaluation of this end point

150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination)

150 minuti (lo studio non prevede visite di follow-up; la rilevazione dell'endpoint è contestuale all'esame PET)

E.5.2

Secondary end point(s)

1. Find the best timing for the acquisition of PET/CT scans able to differentiate between AL and ATTR by comparison with a control group consisting of patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy; 2. Give information on regional ventricular uptake of the radiotracer in relation to the type of amyloidosis by comparison with a control group consisting of patients with left-ventricular non-infiltrative hypertrophic cardiomyopathy.

1. Individuare eventuali cut-off temporali per l'esecuzione dello studio PET cardiaco capaci di differenziare fra AL ed ATTR, rispetto ai pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa utilizzati come gruppo di controllo.
2. Fornire dati di regionalità di captazione ventricolare del radiofarmaco in relazione al tipo di amiloidosi presente, rispetto ai pazienti con ipertrofia ventricolare sinistra di natura non infiltrativa utilizzati come gruppo di controllo.

E.5.2.1

Timepoint(s) of evaluation of this end point

150 minutes (no follow-up visits are needed; the endpoint evaluation is concomitant with the PET examination)

150 minuti (lo studio non prevede visite di follow-up; la rilevazione dell'endpoint è contestuale all'esame PET)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Evaluation of the specificity of the PET tracer [18F]–Florbetaben for cardiac amyloidosis

Valutazione della specificità del tracciante [18F]-Florbetaben per i depositi di amiloide cardiaca.

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

stesso trattamento in 3 popolazioni con caratteristiche cliniche diverse

same treatment in three groups of patient with different clinical conditions

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

enrollment and PET examination of the last patient included in the FLORAMICAR 2 study

arruolamnto ed esame PET dell'ultimo paziente incluso nello studio FLORAMICAR 2

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-06-24.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

the study does not have any plans for treatment after its conclusion, because it has a diagnostic aim.

essendo lo scopo del presente studio di tipo diagnostico, non sono previsti programmi di trattamento una volta conclusa la sperimentazione.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-12-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-18

P. End of Trial
P.	End of Trial Status	Completed

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