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    Clinical Trial Results:
    The Role Of The New Promising Oncological Pet/Ct Tracer [68Ga] Ga-Fapi For Staging Lung Cancer: A Preliminary Study

    Summary
    EudraCT number
    		 2021-006570-23
    Trial protocol
    		 IT  
    Global end of trial date
    30 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2025
    First version publication date
    16 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FAPI-POLMONE-2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Sponsor organisation address
    Via Albertoni 15, Bologna, Italy, 40138
    Public contact
    Dott.ssa Lucia Zanoni, U.O. Medicina Nucleare, IRCCS AOU di Bologna, Policlinico di S.Orsola, Bologna, Italy, zanonilucia84@gmail.com
    Scientific contact
    Dott.ssa Lucia Zanoni, U.O. Medicina Nucleare, IRCCS AOU di Bologna, Policlinico di S.Orsola, Bologna, Italy, zanonilucia84@gmail.com
    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
    08 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aims to evaluate the diagnostic performance of PET / CT with 68Ga-FAPI, in patients with staging lung cancer, in the identification of disease locations by comparing the (overall) evaluation of the 68Ga-FAPI outcome PET / CT with histological data
    Protection of trial subjects
    Yes (insurance)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 May 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    14
    From 65 to 84 years
    48
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment dates: from 26May2022 to 30November2023 Recruitment: Nuclear Medicine, AOU di Bologna, Bologna, Italy

    Pre-assignment
    Screening details
    		 63 subjects underwent the experimental 68Ga-FAPI-46 PET/CT out of the 64 subjects enrolled: 1/64 subjects withdrawed consent before IMP (68Ga-FAPI-46) administration and was excluded from analyses (1 screening failure)

    Period 1
    Period 1 title
    overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Trial Single arm
    Arm description
    		 single arm study Each patient underwent FAPI-PET/CT in addition to its conventional staging flow-chart. No changes in pts management, nor delay in standard diagnostic and therapeutic flow-chart, derived from FAPI-PET/CT results. Treatment plan decided by the referring clinicians on the basis of standard clinical and imaging staging flow-chart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-FAPI-46
    Investigational medicinal product code
    [68Ga-FAPI-46]
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    dosage range 150 to 250 MBq

    Number of subjects in period 1 [1]
    		Overall Trial Single arm
    Started
    63
    Completed
    63
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 63 subjects underwent the experimental 68Ga-FAPI-46 PET/CT out of the overall 64 subjects enrolled: 1/64 subject withdrawed consent before IMP (68Ga-FAPI-46) administration and was excluded from analyses ( 1 screening failure)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 overall Trial Total
    Number of subjects
    		 63 63
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 47 47
        85 years and over
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 71 (45 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 41 41
    Subject analysis sets

    Subject analysis set title
    Surgical
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Pts referred (according to standard practice) to radical surgery, undergoing standard pathology evaluation and routinely monitored (Thoracic surgery Unit) for 1 year

    Subject analysis set title
    Non surgical
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients excluded from surgery, on the basis of standard clinical and imaging staging flow-chart (non-surgical patients): 68Ga-FAPI PET / CT positivity rate and agreement with conventional staging calculated.

    Subject analysis sets values
    		 Surgical Non surgical
    Number of subjects
    50
    13
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    72 (45 to 87)
    67 (52 to 83)
    Gender categorical
    Units: Subjects
        Female
    17
    5
        Male
    33
    8

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial Single arm
    Reporting group description
    		 single arm study Each patient underwent FAPI-PET/CT in addition to its conventional staging flow-chart. No changes in pts management, nor delay in standard diagnostic and therapeutic flow-chart, derived from FAPI-PET/CT results. Treatment plan decided by the referring clinicians on the basis of standard clinical and imaging staging flow-chart.

    Subject analysis set title
    Surgical
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Pts referred (according to standard practice) to radical surgery, undergoing standard pathology evaluation and routinely monitored (Thoracic surgery Unit) for 1 year

    Subject analysis set title
    Non surgical
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients excluded from surgery, on the basis of standard clinical and imaging staging flow-chart (non-surgical patients): 68Ga-FAPI PET / CT positivity rate and agreement with conventional staging calculated.

    Primary: Endpoint 1a (primary): PET/CT diagnostic performance of FAPI, patient-based, for T (n=50)

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    End point title
    		 Endpoint 1a (primary): PET/CT diagnostic performance of FAPI, patient-based, for T (n=50) [1]
    End point description
    Time required for subsequent histological examination (Patients underwent surgery mostly within 2 months from the experimental imaging, with a median of 40.5 days). In pts who underwent surgical treatment, the pathology examination routinely processed of the lung was used as standard of truth to define 68Ga-FAPI PET/CT scans results as true positive (TP), true negative (TN), false positive (FP) or false negative (FN). Sensitivity, specificity, accuracy, positive and negative predictive value (PPV and NPV) were calculated, with relative 95% confidence intervals (95% CI), on a per patient analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for malignant lung lesion (T). FAPI PET/CT results for T: 42 TP 2 FN 2 FP 4 TN
    End point type
    Primary
    End point timeframe
    36 months
    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: According to the trial protocol: sensitivity, specificity, accuracy, PPV and NPV were calculated, with relative 95% confidence intervals (95% CI), on a per patient analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for T.
    End point values
    		 Surgical
    Number of subjects analysed
    50 [2]
    Units: number of sens, spec, ppv, npv, acc
    number (confidence interval 95%)
        sensitivity
    0.955 (0.893 to 1.016)
        specificity
    0.667 (0.289 to 1.044)
        ppv
    0.955 (0.893 to 1.016)
        npv
    0.667 (0.289 to 1.044)
        accuracy
    0.920 (0.845 to 0.995)
    Notes
    [2] - comparison of overall FAPI result with surgical histopathology of lung (T)
    No statistical analyses for this end point

    Primary: Endpoint 1b (primary): PET/CT diagnostic performance of FAPI, patient-based, for N (n=46)

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    End point title
    		 Endpoint 1b (primary): PET/CT diagnostic performance of FAPI, patient-based, for N (n=46) [3]
    End point description
    Time required for subsequent histological examination (Patients underwent surgery mostly within 2 months from the experimental imaging, with a median of 40.5 days). In pts who underwent surgical treatment, the pathology examination of N stations routinely processed was used as standard of truth to define 68Ga-FAPI PET/CT scans results as true positive (TP), true negative (TN), false positive (FP) or false negative (FN). Sensitivity, specificity, accuracy, PPV and NPV was calculated, with relative 95% confidence intervals (95% CI, on a per patient analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for lymph-node stations (N). FAPI PET/CT results for N: 6 TP 6 FN 4 FP 30 TN
    End point type
    Primary
    End point timeframe
    36 months
    Notes
    [3] - 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: According to the trial protocol: sensitivity, specificity, accuracy, PPV and NPV were calculated, with relative 95% confidence intervals (95% CI), on a per patient analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for N.
    End point values
    		 Surgical
    Number of subjects analysed
    46 [4]
    Units: sens, spec, ppv, npv, acc
    number (confidence interval 95%)
        sensitivity
    0.500 (0.217 to 0.783)
        specificity
    0.882 (0.774 to 0.991)
        ppv
    0.600 (0.296 to 0.904)
        npv
    0.833 (0.712 to 0.955)
        accuracy
    0.783 (0.663 to 0.902)
    Notes
    [4] - Among the 50 patients of the surgical cohort, 46 were subjected to lymphadenectomy
    No statistical analyses for this end point

    Secondary: Endpoint 2a: PET/CT diagnostic performance of FAPI, region-based, for T (n=59)

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    End point title
    		 Endpoint 2a: PET/CT diagnostic performance of FAPI, region-based, for T (n=59)
    End point description
    Time required for subsequent histological examination (Patients underwent surgery mostly within 2 months from the experimental imaging, with a median of 40.5 days). Sensitivity, specificity, accuracy, PPV and NPV were calculated, with relative 95% confidence intervals (95% CI), on a per region analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for T. In patients referred for radical surgery, the results of PET/CT were validated by the histopathological examination, performed according to the normal care pathway, of the surgical samples of lung lesioins (T). FAPI PET/CT results for T regions (n=59): TP 45 FN 8 FP 2 TN 4
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Surgical
    Number of subjects analysed
    50 [5]
    Units: sens, spec, ppv, npv, acc
    number (confidence interval 95%)
        sensitivity
    0.849 (0.753 to 0.945)
        specificity
    0.667 (0.289 to 1.044)
        ppv
    0.957 (0.900 to 1.015)
        npv
    0.333 (0.067 to 0.600)
        accuracy
    0.831 (0.735 to 0.926)
    Notes
    [5] - Among the 50 patients of the surgical cohort, 59 lung lesions (T) were examined
    No statistical analyses for this end point

    Secondary: Endpoint 2b: PET/CT diagnostic performance of FAPI, region-based, for N (n=217)

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    End point title
    		 Endpoint 2b: PET/CT diagnostic performance of FAPI, region-based, for N (n=217)
    End point description
    Time required for subsequent histological examination (Patients underwent surgery mostly within 2 months from the experimental imaging, with a median of 40.5 days). Sensitivity, specificity, accuracy, PPV and NPV were calculated, with relative 95% confidence intervals (95% CI), on a N region based analysis, to evaluate the performance of PET / CT with 68Ga-FAPI for N. In patients referred for radical surgery, the results of PET/CT (N) were validated by the surgical histopathological examination, performed according to the normal care pathway, of the resecteted lymphnodes. FAPI PET/CT results for N region: TP 8 FN 7 FP 7 TN 195
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Surgical
    Number of subjects analysed
    46 [6]
    Units: sens, spec, ppv, npv, acc
    number (confidence interval 95%)
        sensitivity
    0.533 (0.281 to 0.786)
        specificity
    0.965 (0.940 to 0.991)
        ppv
    0.533 (0.281 to 0.786)
        npv
    0.965 (0.940 to 0.991)
        accuracy
    0.935 (0.903 to 0.968)
    Notes
    [6] - 46 out of 50 surgical patients addressed to nodal dissection: overall, 217 N-stations examined
    No statistical analyses for this end point

    Secondary: Endpoint 3: concordance of 68Ga-FAPI PET/CT with final conventional staging in pts excluded from radical surgery

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    End point title
    		 Endpoint 3: concordance of 68Ga-FAPI PET/CT with final conventional staging in pts excluded from radical surgery
    End point description
    In pts excluded from surgery, positivity rate was calculated and concordance with conventional Tstaging was assessed
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Non surgical
    Number of subjects analysed
    13 [7]
    Units: %
        % positivity rate FAPI for T
    77
        % positivity rate FAPI for N
    50
        % agreement T between FAPI and biopsy
    60
        % agreement N between FAPI and biopsy
    95
        % agreement T standard FDG PET with biopsy
    60
        % agreement N standard FDG PET with biopsy
    75
    Notes
    [7] - 13 patients not adressed to surgery: 13 T and 20 N regions examined.
    No statistical analyses for this end point

    Secondary: Endpoint 4a: FAPI PET/CT diagnostic performance using semiquantitative PET parameters, region-based, for T

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    End point title
    		 Endpoint 4a: FAPI PET/CT diagnostic performance using semiquantitative PET parameters, region-based, for T
    End point description
    The performance of continuous semiquatitative PET variables (for example SUVmax and target to background ratios-TBRs) were evaluated in relation to the result of the histological examination of T, when available. MBP=mediastinal blood pool AUC= area under the curve
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Surgical
    Number of subjects analysed
    50 [8]
    Units: AUC
    number (confidence interval 95%)
        AUC SUVmax-T (Tmax)
    0.61 (0.3342 to 0.889)
        AUC TBR-L (Tmax/Liver mean)
    0.64 (0.3347 to 0.9389)
        AUC TBR-MBP (Tmax/MBP mean)
    0.65 (0.3573 to 0.9445)
        AUC TBR-P (Tmax/Lung mean)
    0.63 (0.3226 to 0.9415)
    Notes
    [8] - Among the 50 patients of the surgical cohort, 59 lung lesions (T) were examined
    No statistical analyses for this end point

    Secondary: Endpoint 4b: FAPI PET/CT diagnostic performance using semiquantitative PET parameters, region-based, for N

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    End point title
    		 Endpoint 4b: FAPI PET/CT diagnostic performance using semiquantitative PET parameters, region-based, for N
    End point description
    The performance of continuous semiquatitative PET variables (for example SUVmax and TBR) were evaluated in relation to the result of the histological examination, when available.
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Surgical
    Number of subjects analysed
    46 [9]
    Units: AUC
    number (confidence interval 95%)
        AUC SUVmax-N (Nmax)
    0.79 (0.6477 to 0.9099)
        AUC TBR-L (Nmax/Liver mean)
    0.78 (0.6538 to 0.9099)
        AUC TBR-MBP (Nmax/MBP mean)
    0.78 (0.6477 to 0.9094)
        AUC TBR-P (Nmax/Lung mean)
    0.78 (0.6465 to 0.9071)
    Notes
    [9] - 46 out of 50 surgical patients addressed to nodal dissection: overall, 217 N-stations examined.
    No statistical analyses for this end point

    Secondary: Endpoint 5: comparison hypothetical treatment plan derived from 68Ga-FAPI with the conventional treatment already performed

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    End point title
    		 Endpoint 5: comparison hypothetical treatment plan derived from 68Ga-FAPI with the conventional treatment already performed
    End point description
    At the end of the standard management of pts included in the study, a hypothetical treatment plan using the FAPI-PET/CT results was defined. The conventional and already performed treatment plan (derived from the conventional staging flow-chart) and the hypothetical one (derived from FAPI) were compared to assess a only theoretical potential clinical impact of the new tracer in the next future. final TNMstaging (stageI-IV) assessed by AJCC8thEdition.
    End point type
    Secondary
    End point timeframe
    End of Trial
    End point values
    		 Surgical
    Number of subjects analysed
    50 [10]
    Units: agreement %
        % agreement fapi-histology TNM
    48
        % agreement fdg-histology TNM
    43
        % FAPI-FDG discordant cases
    30
        % FDG-derived correct surgical management
    69
        % FAPI-derived correct surgical management
    87
    Notes
    [10] - surgical cohort (TNM final staging determined by surgical histopathology as standard of truth)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    1 month from FAPI PET/CT ( as per protocol)
    Adverse event reporting additional description
    no
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 63 (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: There are not recorded adverse events for the timeframe

    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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