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    Summary
    EudraCT Number:2020-005549-17
    Sponsor's Protocol Code Number:FAPI-MN-2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005549-17
    A.3Full title of the trial
    Role of [68Ga]Ga-FAPI PET/CT in oncological patients with doubtful or inconclusive findings at [18F]F-FDG PET/CT
    Ruolo della PET/TC con 68Ga-FAPI nei pazienti in cui la PET/TC con 18F-FDG sia risultata dubbia o inconcludente per patologia oncologica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of [68Ga]Ga-FAPI PET/CT in oncological patients with doubtful or inconclusive findings at [18F]F-FDG PET/CT
    Ruolo della PET/TC con 68Ga-FAPI nei pazienti in cui la PET/TC con 18F-FDG sia risultata dubbia o inconcludente per patologia oncologica
    A.3.2Name or abbreviated title of the trial where available
    FAPI-MN-2020
    FAPI-MN-2020
    A.4.1Sponsor's protocol code numberFAPI-MN-2020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAOU di Bologna Policlinico S.Orsola
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna Policlinico S.Orsola
    B.5.2Functional name of contact pointU.O. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.6E-mailstefano.fanti@aosp.bo.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[68Ga]Ga-FAPI-46
    D.3.2Product code [68GaGa-FAPI-46]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[68Ga]Ga-FAPI-46
    D.3.9.2Current sponsor code[68Ga]Ga-FAPI-46
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    oncological disease suspicion/ new diagnosis or with a previously treated tumour, with an inconclusive or equivocal findings after the standard clinical/diagnostic flow chart: [18F]F-FDG PET/CT imaging not able to solve the clinical doubt
    neoplasia sospetta o di nuova diagnosi o trattata in precedenza, di qualsiasi istologia, in cui l’esame PET/TC con 18F-FDG, eseguito nell’ambito del normale percorso assistenziale, risulti dubbio per la presenza di malattia o inconcludente nel soddisfare il quesito clinico
    E.1.1.1Medical condition in easily understood language
    oncological disease suspicion/ new diagnosis or with a previously treated tumour, with an inconclusive or equivocal findings after the standard clinical/diagnostic flow chart: [18F]F-FDG PET/CT
    neoplasia sospetta o di nuova diagnosi o trattata in precedenza, in cui l’esame PET/TC con 18F-FDG, eseguito nell’ambito del normale percorso assistenziale, risulti dubbio o inconcludente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study aims to evaluate the accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care path, the diagnostic doubt remains: examination PET / CT with 18F-FDG resulted doubtful for the presence of oncological disease or inconclusive in satisfying this diagnostic question.
    Lo studio si propone di valutare l’accuratezza della PET/TC con 68Ga-FAPI nel rilevare la presenza di malattia in pazienti per i quali, al completamento delle procedure diagnostiche cliniche e strumentali previste dal loro normale percorso assistenziale, permanga il dubbio diagnostico: esame PET/TC con 18F-FDG risultato dubbio per la presenza di malattia oncologica o inconcludente nel soddisfare tale quesito diagnostico.
    E.2.2Secondary objectives of the trial
    A second objective is to evaluate the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI compared to PET / CT with 18F-FDG (standard tracer currently used in various cancer settings).
    Un secondo obiettivo consiste nel valutare l’accuratezza, sensibilità e specificità della PET/TC con 68Ga-FAPI rispetto alla PET/TC con 18F-FDG (tracciante standard attualmente utilizzato in diversi setting oncologici).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age =18 years old
    • Both sexes
    • Patients with suspected or newly diagnosed or previously treated neoplasm (prior therapies of at least 3 months), in the presence of inconclusive FDG findings such as:
    - Suspect primary or secondary (lymph-nodes or distant metastases) lesions with absent/faint FDG uptake (SUVmax<liver SUVmax) or low TBR;
    - And/or suspect primary or secondary (lymph-nodes or distant metastases) lesions in a site of phisiological FDG uptake (such as brain or liver) or in sites in which FDG has a low sensitivity (i.e. peritoneal carcinomatosis, esophageal-gastro-intestinal tract);
    - And/or low glucose metabolism tumour hystotypes (i.e. renal clear cell carcinoma, mucinous mammary tumours, well differentiated HCC);
    - And/or differential diagnosis between tumour and inflammation (i.e. determining lymph-nodes benign or malignant nature in head/neck cancers, differential diagnosis between inflammation or malignant tissue in sarcomas).
    • Signed informed consent
    • Età =18anni
    • Entrambi i sessi
    • Pazienti con neoplasia sospetta o di nuova diagnosi o trattata in precedenza (terapie antecedenti di almeno 3 mesi), in presenza di reperti FDG inconclusivi quali:
    - lesioni sospette primitive, linfonodali o metastatiche che presentino assente/minima fissazione del radiofarmaco oppure un basso TBR;
    - e/o sospette lesioni primitive o secondarie in un sito di fisiologica fissazione di FDG (cervello, fegato) o in distretti in cui l’FDG ha dimostrato una scarsa sensibilità (es. carcinomatosi peritoneale, stomaco, esofago);
    - e/o istotipi tumorali a basso metabolismo glucidico (es. carcinoma renale a cellule chiare, tumori mucinosi della mammella, epatocarcinoma ben differenziato);
    - e/o con reperti in diagnosi differenziale tra oncologici ed infiammatori (es. determinazione dell'infiltrazione dei linfonodi nei tumori della testa e del collo, distinzione tra infiammazione o malattia attiva nei sarcomi).
    • Firma del consenso informato.
    E.4Principal exclusion criteria
    • Pregnant women. The state of pregnancy in women of childbearing potential will be ascertained by measuring serum ß-hCG.
    • Breastfeeding women
    • Patients in emergency situations or unable to understand and want
    • History of allergic reactions or hypersensitivity to the active substance, to any of the excipients, or to any of the components of the radiolabelled radiopharmaceutical
    • Contraindication to PET / CT examination for patients unable to perform PET due to weight, claustrophobia or the inability to remain still for the duration of the examination
    • Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives before the study drug
    • Patients with impaired renal function;
    • Patients with impaired liver function.
    • Donne in stato di gravidanza. Lo stato di gravidanza nelle donne potenzialmente fertili verrà accertato tramite la misura della ß-hCG sierica.
    • Donne in allattamento
    • Pazienti in situazioni di emergenza o non in grado di intendere e di volere
    • Anamnesi di reazioni allergiche o ipersensibilità al principio attivo, a uno qualsiasi degli eccipienti, o a uno qualsiasi dei componenti del radiofarmaco marcato
    • Controindicazione all’esame PET/TC per pazienti non in grado di eseguire la PET a causa del peso, della claustrofobia o dell'incapacità di rimanere fermi per tutta la durata dell'esame
    • Partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite prima del farmaco in studio
    • Pazienti con funzione renale compromessa;
    • Pazienti con funzione epatica alterata.
    E.5 End points
    E.5.1Primary end point(s)
    Accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care pathway, the diagnostic doubt remains: PET / CT examination with 18F-FDG result doubt for the presence of oncological disease or inconclusive in satisfying this diagnostic question.
    The findings will be evaluated as positive (PET FAPI +) if the SUVmax of the radiopharmaceutical in a specific VOI that fully includes the lesion is> the SUVmean of the background (surrounding tissues) which will be calculated in a VOI of 1 cm 10 min after administration.
    The findings will be judged negative (PET FAPI-) if they do not show uptake of the radiopharmaceutical or an uptake lower than the surrounding background (SUVmax doubtful finding / SUVmean of the background =1.
    The results of the PET / CT survey with 68Ga-FAPI will be evaluated as TRUE POSITIVE / FALSE POSITIVE / TRUE NEGATIVE and FALSE NEGATIVE based on the result of the histological examination if available otherwise based on the comparison with the follow-up investigations over 12 months following the experimental investigation.
    The accuracy of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula:
    (TRUE POSITIVE + TRUE NEGATIVE) / TOTAL PATIENTS
    Accuratezza della PET/TC con 68Ga-FAPI nel rilevare la presenza di malattia in pazienti per i quali, al completamento delle procedure diagnostiche cliniche e strumentali previste dal loro normale percorso assistenziale, permanga il dubbio diagnostico: esame PET/TC con 18F-FDG risultato dubbio per la presenza di malattia oncologica o inconcludente nel soddisfare tale quesito diagnostico.
    I reperti verranno valutati come positivi (PET FAPI+) se il SUVmax del radiofarmaco in una VOI specifica che include interamente la lesione è > del SUVmean del background (tessuti circostanti) che verrà calcolato in una VOI di 1 cm a 10 min dalla somministrazione.
    I reperti verranno giudicati negativi (PET FAPI-) se non presenteranno captazione del radiofarmaco ovvero una captazione inferiore al background circostante (SUVmax reperto dubbio/SUVmean del background =1.
    I risultati dell’indagine PET/TC con 68Ga-FAPI verranno valutati come VERI POSITIVI/ FALSI POSITIVI/ VERI NEGATIVI e FALSI NEGATIVI sulla base del risultato dell’ esame istologico se disponibile altrimenti sulla base del confronto con le indagini di follow up nei 12 mesi successivi all’indagine sperimentale.
    L’accuratezza della PET/TC con 68Ga-FAPI verrà calcolata con la seguente formula statistica:
    (VERI POSITIVI+VERI NEGATIVI)/TOTALE PAZIENTI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time required for the subsequent histological examination, when available, or for the clinical outcome (12 months follow up).
    Tempo necessario per il successivo esame istologico, quando disponibile, oppure per l'outcome clinico (follow up di 12 mesi).
    E.5.2Secondary end point(s)
    Evaluation of the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI and PET / CT with 18F-FDG in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal course care, the diagnostic doubt remains: PET / CT examination with 18F-FDG resulted in doubt due to the presence of oncological disease or inconclusive in satisfying this diagnostic question.
    The findings will be evaluated as positive (PET FAPI +) if the SUVmax of the radiopharmaceutical in a specific VOI that fully includes the lesion is> the SUVmean of the background (surrounding tissues) which will be calculated in a VOI of 1 cm 10 min after administration.
    The findings will be judged negative (PET FAPI-) if they do not show uptake of the radiopharmaceutical or an uptake lower than the surrounding background (SUVmax doubtful finding / SUVmean of the background =1.
    Findings will be evaluated as positive (PET FDG +) if the radiopharmaceutical SUVmax in a VOI that fully includes the lesion is> 2.
    Findings will be evaluated as positive (PET FDG-) if the radiopharmaceutical SUVmax in a VOI that fully includes the lesion is = 2.

    The results of PET / CT investigations with 68Ga-FAPI and 18F-FDG will be evaluated as TRUE POSITIVE / FALSE POSITIVE / TRUE NEGATIVE and FALSE NEGATIVE based on the result of the histological examination if available otherwise based on the comparison with the follow up investigations in the 12 months following the experimental investigation.
    The accuracy of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the following statistical formula:
    (TRUE POSITIVE + TRUE NEGATIVE) / TOTAL PATIENTS
    The sensitivity of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the following statistical formula:
    TRUE POSITIVE / (TRUE POSITIVE + FALSE NEGATIVE)
    The specificity of PET / CT with 68Ga-FAPI and with 18F-FDG will be calculated with the following statistical formula:
    TRUE NEGATIVE / (TRUE NEGATIVE + FALSE POSITIVE)
    Then the accuracy, sensitivity and specificity calculated for PET / CT with 68Ga-FAPI and 18F-FDG PET / CT will be compared.
    Valutazione dell’accuratezza, sensibilità e specificità della PET/TC con 68Ga-FAPI e della PET/TC con 18F-FDG nel rilevare la presenza di malattia in pazienti per i quali, al completamento delle procedure diagnostiche cliniche e strumentali previste dal loro normale percorso assistenziale, permanga il dubbio diagnostico: esame PET/TC con 18F-FDG risultato dubbio per la presenza di malattia oncologica o inconcludente nel soddisfare tale quesito diagnostico.
    I reperti verranno valutati come positivi (PET FAPI+) se il SUVmax del radiofarmaco in una VOI specifica che include interamente la lesione è > del SUVmean del background (tessuti circostanti) che verrà calcolato in una VOI di 1 cm a 10 min dalla somministrazione.
    I reperti verranno giudicati negativi (PET FAPI-) se non presenteranno captazione del radiofarmaco ovvero una captazione inferiore al background circostante (SUVmax reperto dubbio/SUVmean del background =1.
    I reperti verranno valutati come positivi (PET FDG+) se il SUVmax del radiofarmaco in una VOI che include interamente la lesione è > 2.
    I reperti verranno valutati come positivi (PET FDG-) se il SUVmax del radiofarmaco in una VOI che include interamente la lesione è = 2.

    I risultati delle indagini PET/TC con 68Ga-FAPI e 18F-FDG verranno valutati come VERI POSITIVI/ FALSI POSITIVI/ VERI NEGATIVI e FALSI NEGATIVI sulla base del risultato dell’esame istologico se disponibile altrimenti sulla base del confronto con le indagini di follow up nei 12 mesi successivi all’indagine sperimentale.
    L’accuratezza della PET/TC con 68Ga-FAPI e con 18F-FDG verrà calcolata con la seguente formula statistica:
    (VERI POSITIVI+VERI NEGATIVI)/TOTALE PAZIENTI
    La sensibilità della PET/TC con 68Ga-FAPI e con 18F-FDG verrà calcolata con la seguente formula statistica:
    VERI POSITIVI/(VERI POSITIVI+FALSI NEGATIVI)
    La specificità della PET/TC con 68Ga-FAPI e con 18F-FDG verrà calcolata con la seguente formula statistica:
    VERI NEGATIVI/(VERI NEGATIVI+FALSI POSITIVI)
    Poi verranno confrontate la accuratezza, sensibilità e specificità calcolate per la PET/TC con 68Ga-FAPI e 18F-FDG PET/TC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time required for the subsequent histological examination, when available, or for the clinical outcome (12 months follow up).
    Tempo necessario per il successivo esame istologico, quando disponibile, oppure per l'outcome clinico (follow up di 12 mesi).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women 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 2021-06-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Standard care pathway
    Normale percorso assistenziale
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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