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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2017-001660-38
    Trial protocol
    		 IT  
    Global end of trial date
    31 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2021
    First version publication date
    19 Nov 2021
    Other versions
    Summary report(s)
    		 Floramicar 2 trial report results

    Trial information

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    Trial identification
    Sponsor protocol code
    FLORAMICAR2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FONDAZIONE TOSCANA 'GABRIELE MONASTERIO'
    Sponsor organisation address
    VIA TRESTE, PISA, Italy,
    Public contact
    U.O.C. Farmaceutica Ospedaliera, Fondazione Toscana Gabriele Monasterio, +39 0585493507, farmacisti@ftgm.it
    Scientific contact
    U.O.C. Farmaceutica Ospedaliera, Fondazione Toscana Gabriele Monasterio, +39 0585493507, farmacisti@ftgm.it
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    Protection of trial subjects
    The study protocol conformed to the 1975 Declaration of Helsinki and was approved by the institutional ethics committee and by the Agenzia Italiana del Farmaco committee (EudraCT number: 2017- 001660-38); all patients provided written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    40
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients <20 years of age and those with coronary artery disease, chronic liver diseases, and severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73 m2) were excluded.

    Pre-assignment
    Screening details
    		 Forty patients with biopsy-proven diagnoses of CA (20 ALs and 20 ATTRs) and 20 patients referred to our tertiary center with the initial clinical suspicion of CA and then diagnosed with non-CA conditions were prospectively enrolled and underwent PET/CT with [18F]-florbetaben.

    Period 1
    Period 1 title
    [18F]-Florbetaben PET/CT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AL CA
    Arm description
    		 20 patients with biopsy-proven diagnoses of AL CA
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetaben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    infusion of 300 MBq/ml of [18F]-Florbetaben followed by a saline flush of 10 ml (1 ml/s);

    Arm title
    		 ATTRs CA
    Arm description
    		 20 patients with biopsy-proven diagnoses of ATTRs CA
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetaben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    infusion of 300 MBq/ml of [18F]-Florbetaben followed by a saline flush of 10 ml (1 ml/s);

    Arm title
    		 No-CA
    Arm description
    		 20 patients referred to our tertiary center with the initial clinical suspicion of CA and then diagnosed with non-CA conditions
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetaben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    infusion of 300 MBq/ml of [18F]-Florbetaben followed by a saline flush of 10 ml (1 ml/s);

    Number of subjects in period 1
    		AL CA ATTRs CA No-CA
    Started
    20
    20
    20
    Completed
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    [18F]-Florbetaben PET/CT
    Reporting group description
    		 -

    Reporting group values
    		 [18F]-Florbetaben PET/CT Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        18-85
    		 60 60
    Gender categorical
    Units: Subjects
        Female
    		 17 17
        Male
    		 43 43
    Subject analysis sets

    Subject analysis set title
    Results
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CLINICAL CHARACTERISTICS. Clinical characteristics and echocardiographic features of the subjects are summarized in Table 1. Representative histological patterns are shown in Figure 1. Patients with ATTR, compared with those with AL and non-CA, were older and presented with higher left atrial volume and left ventricular mass index (23.5  4.5 ml/m2; p ¼ 0.003 vs. non-CA; and 129  39 g/m2; p ¼ 0.003 vs. non-CA, respectively). Furthermore, whereas patients with CA presented with worse diastolic dysfunction, no difference could be observed in terms of left ventricular systolic function when patients with CA were compared with patients with non-CA. CARDIAC PET/CT CHARACTERISTICS. Static images qualitative analysis. A total of 240 static cardiac scans (4 scans per patient: early; intermediate; late; and delayed) were evaluated by 2 independent observers. Images indicated a significant radiotracer myocardial uptake in 121 of 240 scans (50%).

    Subject analysis sets values
    		 Results
    Number of subjects
    60
    Age categorical
    Units: Subjects
        18-85
    60
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    17
        Male
    43

    End points

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    End points reporting groups
    Reporting group title
    AL CA
    Reporting group description
    		 20 patients with biopsy-proven diagnoses of AL CA

    Reporting group title
    ATTRs CA
    Reporting group description
    		 20 patients with biopsy-proven diagnoses of ATTRs CA

    Reporting group title
    No-CA
    Reporting group description
    		 20 patients referred to our tertiary center with the initial clinical suspicion of CA and then diagnosed with non-CA conditions

    Subject analysis set title
    Results
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CLINICAL CHARACTERISTICS. Clinical characteristics and echocardiographic features of the subjects are summarized in Table 1. Representative histological patterns are shown in Figure 1. Patients with ATTR, compared with those with AL and non-CA, were older and presented with higher left atrial volume and left ventricular mass index (23.5  4.5 ml/m2; p ¼ 0.003 vs. non-CA; and 129  39 g/m2; p ¼ 0.003 vs. non-CA, respectively). Furthermore, whereas patients with CA presented with worse diastolic dysfunction, no difference could be observed in terms of left ventricular systolic function when patients with CA were compared with patients with non-CA. CARDIAC PET/CT CHARACTERISTICS. Static images qualitative analysis. A total of 240 static cardiac scans (4 scans per patient: early; intermediate; late; and delayed) were evaluated by 2 independent observers. Images indicated a significant radiotracer myocardial uptake in 121 of 240 scans (50%).

    Primary: This study aimed to test the diagnostic value of [18F]–florbetaben positron emission tomography (PET) in patients with suspicion of CA.

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    End point title
    		 This study aimed to test the diagnostic value of [18F]–florbetaben positron emission tomography (PET) in patients with suspicion of CA.
    End point description
    A significant difference in retention index (RI) among patients with AL (red) and those with either ATTR (green) or non-CA (blue) is found within the 20- to 60-min period of observation. No significant difference was found between ATTR and non-CA RI during the whole dynamic acquisition.
    End point type
    Primary
    End point timeframe
    only one acquisition
    End point values
    		 AL CA ATTRs CA No-CA
    Number of subjects analysed
    20
    20
    20
    Units: SUVmean values
        number (not applicable)
    4.70
    1.45
    1.60
    Attachments
    		 Untitled (Filename: j.jcmg.2020.05.031.pdf)
    Statistical analysis title
    		 results
    Comparison groups
    ATTRs CA v AL CA v No-CA
    Number of subjects included in analysis
    60
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - Normal distribution was assessed by the Kolmogorov-Smirnov test; continuous variables with normal distribution were presented as mean  SD, whereas those with non-normal distribution were presented as median (interquartile range [IQR]); and categorical variables were shown as percentages. Differences among groups were tested by 1-way analysis of variance on ranks (Kruskal-Wallis H test) or by chi-square test, as appropriate.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    all study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 -

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: NO SAE OR AE REGISTERED DURING THE STUDY

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    na

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32771577
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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