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    Clinical Trial Results:
    A prospective single-arm, monocentric, phase-II explorative study on evaluation of diagnostic use of the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyloidosis

    Summary
    EudraCT number
    		 2015-005384-16
    Trial protocol
    		 IT  
    Global end of trial date
    23 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2022
    First version publication date
    26 May 2022
    Other versions
    Summary report(s)
    		 Floramicar Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    FLORAMICAR
    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 trieste , 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
    30 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Establish the affinity of the tracer [18F] -Florbetaben for amyloid deposits in patients with clinican suspition of cardiac amyloidosis AL and ATTR.
    Protection of trial subjects
    Study protocol was conformed to the 1975 Declaration of Helsinki. It was approved by the institutional ethics committee and by the Agenzia Italiana del Farmaco committee; all patients provided written informed consent.
    Background therapy
    		 na
    Evidence for comparator
    		 na
    Actual start date of recruitment
    23 Jun 2016
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    10
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Age>20 years, high clinical suspicion of cardiac amyloidosis based on cardiac examination, biomarkers (Nt-proBNP, HS-TnT, immunoglobulin light chains in serum and urine, plasma protein electrophoresis and serum free light chains), baseline ECG, baseline echocardiography, cardiac MRI, histological evidence of amyloid (Congo red stain).

    Pre-assignment
    Screening details
    		 Age>20 years, high clinical suspicion of cardiac amyloidosis based on cardiac examination, biomarkers (Nt-proBNP, HS-TnT, immunoglobulin light chains in serum and urine, plasma protein electrophoresis and serum free light chains), baseline ECG, baseline echocardiography, cardiac MRI, histological evidence of amyloid (Congo red stain).

    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
    Arm title
    		 Patient with CA
    Arm description
    		 Patient with CA
    Arm type
    		 Experimental

    Investigational medicinal product name
    florbetaben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Solution for 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
    		Patient with CA
    Started
    12
    Completed
    12

    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
    		 12 12
    Age categorical
    Units: Subjects
        18-85
    		 12 12
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    18-85
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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
    		 18-85
    Number of subjects
    12
    Age categorical
    Units: Subjects
        18-85
    12
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    12

    End points

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    End points reporting groups
    Reporting group title
    Patient with CA
    Reporting group description
    		 Patient with CA

    Subject analysis set title
    18-85
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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: CA

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    End point title
    		 CA
    End point description
    End point type
    Primary
    End point timeframe
    only one acquisition
    End point values
    		 Patient with CA 18-85
    Number of subjects analysed
    12
    12
    Units: SUV mean values
    12
    12
    Attachments
    		 results
    Statistical analysis title
    		 results
    Comparison groups
    Patient with CA v 18-85
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    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 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    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 / 12 (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.
    None reported
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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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