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    Clinical Trial Results:
    An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) for localization of oral and oropharyngeal squamous cell carcinoma

    Summary
    EudraCT number
    2022-001361-12
    Trial protocol
    DK  
    Global end of trial date
    11 Jul 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Mar 2024
    First version publication date
    29 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FG001-CT-003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    FluoGuide A/S
    Sponsor organisation address
    Ole Maaløes Vej 3, Copenhagen, Denmark, DK-2200
    Public contact
    Andreas Kjær, MD, PhD, DMSc Chief Medical Officer, FluoGuide A/S, +45 3131 0844,
    Scientific contact
    Andreas Kjær, MD, PhD, DMSc Chief Medical Officer, FluoGuide A/S, +45 3131 0844,
    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
    03 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate FG001 for the detection of oral and oropharyngeal cancer
    Protection of trial subjects
    The trial was conducted, in compliance with the protocol, regulatory requirements, Good Clinical Practice (GCP) and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association. All subjects provided written informed consent to participate in the trial prior to being screened. All subjects received written and verbal information regarding the trial. The given information emphasized that participation in the trial was voluntary and that the subjects could withdraw from the trial at any time and for any reason. All subjects were given the opportunity to ask questions about the trial and were given sufficient time to decide whether to participate in the trial. A subject was discontinued from the trial at any time if the subject, the Investigator, or the FluoGuide A/S evaluated that it was not in the subject´s best interest to continue. The following were possible reasons for trial treatment discontinuation: • Subject withdrawal of consent. • Subject was not compliant with trial procedures. • AE that in the opinion of the Investigator was in the best interest of the subject to discontinue trial participation. • Protocol violation requiring discontinuation. • Lost to follow-up. • FluoGuide A/S request for early termination of trial. • Subject death. All subjects could withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. Reasonable attempts were made by the Investigator to provide a reason for the subject’s withdrawal. The reason for the subject’s withdrawal from the trial was specified in the subject’s journal and the eCRF. If a subject was withdrawn from treatment due to an AE, the subject was followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized. Although subjects could withdraw from the trial at any time and for any reason, subject withdrawal was avoided to the extent possible.
    Background therapy
    None.
    Evidence for comparator
    None.
    Actual start date of recruitment
    18 Nov 2022
    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
    Denmark: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    5
    From 65 to 84 years
    11
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at Copenhagen University Hospital, Rigshospitalet, Denmark. A total of 20 subjects were screened and 17 subjects were finally enrolled in the trial: four were included in the FG001 36 mg group, eight in the FG001 16 mg group and five in the FG001 4 mg group. One subject was withdrawn due to being inoperative.

    Pre-assignment
    Screening details
    At the screening visit the subject´s medical history and concomitant illnesses were obtained, and the previous and concomitant medication documented.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    FG001 36 mg
    Arm description
    Four subjects received FG001 at a dose of 36 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The FG001 DP i.v. consisted of a vial containing 5.2 mg freeze-dried FG001 for reconstitution with sterile water for injection (sWfI) prior to use. All subjects received a single dose, slowly i.v. injection (up to 10 minutes) of the IMP (batch numbers: B4002507 and B4003582).

    Arm title
    FG001 16 mg
    Arm description
    Eight subjects received FG001 at a dose of 16 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The FG001 DP i.v. consisted of a vial containing 5.2 mg freeze-dried FG001 for reconstitution with sterile water for injection (sWfI) prior to use. All subjects received a single dose, slowly i.v. injection (up to 10 minutes) of the IMP (batch numbers: B4002507 and B4003582).

    Arm title
    FG001 4 mg
    Arm description
    Five subjects received FG001 at a dose of 4 mg. One subject discontinued the trial by physician’s decision since the subject had no valid TBR imaging information.
    Arm type
    Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The FG001 DP i.v. consisted of a vial containing 5.2 mg freeze-dried FG001 for reconstitution with sterile water for injection (sWfI) prior to use. All subjects received a single dose, slowly i.v. injection (up to 10 minutes) of the IMP (batch numbers: B4002507 and B4003582).

    Number of subjects in period 1
    FG001 36 mg FG001 16 mg FG001 4 mg
    Started
    4
    8
    5
    Completed
    4
    8
    4
    Not completed
    0
    0
    1
         Physician decision
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FG001 36 mg
    Reporting group description
    Four subjects received FG001 at a dose of 36 mg.

    Reporting group title
    FG001 16 mg
    Reporting group description
    Eight subjects received FG001 at a dose of 16 mg.

    Reporting group title
    FG001 4 mg
    Reporting group description
    Five subjects received FG001 at a dose of 4 mg. One subject discontinued the trial by physician’s decision since the subject had no valid TBR imaging information.

    Reporting group values
    FG001 36 mg FG001 16 mg FG001 4 mg Total
    Number of subjects
    4 8 5 17
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    2 2 1 5
        From 65-84 years
    2 6 3 11
        85 years and over
    0 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.0 ( 21.0 ) 69.4 ( 12.1 ) 69.0 ( 16.5 ) -
    Gender categorical
    Units: Subjects
        Female
    1 3 4 8
        Male
    3 5 1 9

    End points

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    End points reporting groups
    Reporting group title
    FG001 36 mg
    Reporting group description
    Four subjects received FG001 at a dose of 36 mg.

    Reporting group title
    FG001 16 mg
    Reporting group description
    Eight subjects received FG001 at a dose of 16 mg.

    Reporting group title
    FG001 4 mg
    Reporting group description
    Five subjects received FG001 at a dose of 4 mg. One subject discontinued the trial by physician’s decision since the subject had no valid TBR imaging information.

    Primary: Sensitivity for Detection of Oral and Oropharyngeal Cancer Verified by Histology

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    End point title
    Sensitivity for Detection of Oral and Oropharyngeal Cancer Verified by Histology [1]
    End point description
    The sensitivity was evaluated as the proportion of subjects with fluorescent tumors given the tumor had been histologically verified. The efficacy of FG001 (as a tumor imaging agent) was examined by the sensitivity, which was verified via the intensity of fluorescence from the specimen sampled. As per standard procedure at site the histopathological evaluation of a section of the tumor was performed. A positive result was defined as correspondence between presence of cancer tissue in the biopsy sampled in an area with optical signal within the macroscopically visible tumor.
    End point type
    Primary
    End point timeframe
    During surgery, punch biopsies were sampled to confirm sensitivity histopathologically.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not applicable.
    End point values
    FG001 36 mg FG001 16 mg FG001 4 mg
    Number of subjects analysed
    4
    8
    4
    Units: Subjects
        Subjects with a positive test result
    4
    8
    4
    No statistical analyses for this end point

    Secondary: Tumor To Background Ratio (TBR): Signal intensity in tumor

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    End point title
    Tumor To Background Ratio (TBR): Signal intensity in tumor
    End point description
    The optimal image for each subject was annotated for the tumor and three representative backgrounds (suspected healthy tissue). On the selected image, the tumor was annotated (delineated) based on the surgeon´s knowledge of where the tumor was placed (including depth of tumor, as applicable). Hereafter, the areas of the anticipated healthy tissue were annotated as backgrounds. These were annotated as large areas near the tumor but anticipated not to be part of the tumor, both in vivo and ex vivo, for all subjects. An annotation tool was used for this and generated a pixel-based intensity value (range from 0-255). From the intensity values, a TBR was calculated.
    End point type
    Secondary
    End point timeframe
    TBR was a secondary efficacy endpoint and was calculated as the fluorescence of the tumor relative to background tissue, as measured by NIR imaging. This was imaged in situ during resection.
    End point values
    FG001 36 mg FG001 16 mg FG001 4 mg
    Number of subjects analysed
    4
    8
    4
    Units: unit(s)
    median (inter-quartile range (Q1-Q3))
        Intensity Max (cancer)
    159.82 (142.97 to 187.67)
    157.07 (153.21 to 168.57)
    169.77 (158.87 to 181.90)
        Intensity Mean (cancer)
    122.68 (106.92 to 144.38)
    114.50 (104.74 to 126.61)
    114.08 (107.24 to 129.79)
        Intensity Background
    52.35 (45.31 to 64.53)
    56.36 (48.60 to 62.43)
    53.54 (46.33 to 68.13)
        TBR Max value
    3.08 (2.70 to 3.46)
    2.94 (2.56 to 3.15)
    3.26 (2.72 to 3.43)
        TBR Mean value
    2.27 (2.18 to 2.44)
    2.04 (1.91 to 2.18)
    2.32 (1.90 to 2.37)
    No statistical analyses for this end point

    Secondary: PK profile determined by non-compartmental analysis

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    End point title
    PK profile determined by non-compartmental analysis
    End point description
    End point type
    Secondary
    End point timeframe
    Samples were used to evaluate the PKs of FG001 and were taken at the following timepoints from administration of FG001: +1 Hour (± 15 minutes), +13 hours (±2 hours), +24 hours (± 4 hours), +36 hours (± 4 hours), and +44 hours (± 6 hours).
    End point values
    FG001 36 mg FG001 16 mg FG001 4 mg
    Number of subjects analysed
    4 [2]
    8 [3]
    5 [4]
    Units: unit(s)
    arithmetic mean (standard deviation)
        Cmax (ng/mL)
    8130 ( 1360 )
    4300 ( 1200 )
    577 ( 373 )
        tmax (hr)
    1.14 ( 0.0438 )
    1.08 ( 0.111 )
    3.38 ( 5.26 )
        AUC0-inf (hr*ng/mL)
    139000 ( 29600 )
    71300 ( 27400 )
    0 ( 0 )
        AUC0-last (hr*ng/mL)
    129000 ( 25500 )
    66300 ( 22800 )
    11400 ( 7270 )
        t1/2 (hr)
    11.2 ( 1.38 )
    12.3 ( 0.810 )
    0 ( 0 )
    Notes
    [2] - N Cmax=4 N tmax=4 N AUC0-inf=4 N AUC0-last=4 N t1/2=4
    [3] - N Cmax=8 N tmax=8 N AUC0-inf=7 N AUC0-last=8 N t1/2=7
    [4] - N Cmax=5 N tmax=5 N AUC0-inf=0 N AUC0-last=3 N t1/2=0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety was closely followed during the course of the trial.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    FG001 36 mg
    Reporting group description
    Four subjects received FG001 at a dose of 36 mg.

    Reporting group title
    FG001 16 mg
    Reporting group description
    Eight subjects received FG001 at a dose of 16 mg.

    Reporting group title
    FG001 4 mg
    Reporting group description
    Five subjects received FG001 at a dose of 4 mg. One subject discontinued the trial by physician’s decision since the subject had no valid TBR imaging information.

    Serious adverse events
    FG001 36 mg FG001 16 mg FG001 4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    FG001 36 mg FG001 16 mg FG001 4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    8 / 8 (100.00%)
    4 / 5 (80.00%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    4 / 4 (100.00%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    4
    2
    1
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    5 / 8 (62.50%)
    4 / 5 (80.00%)
         occurrences all number
    1
    5
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2023
    This change was made to update the Interim Evaluation (IE). Description of changes: • Inclusion of a dosing visit the day before surgery. • Inclusion of the safety data as part of the IE meeting. • Update of the IE. • Inclusion of a new exclusion criterion (INR<1.7). • Correction of minor inconsistencies.

    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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