Multisenter valideringsforsøk av [18F]AlF-FAPI-74 for PET-avbildning av kreftassosierte fibroblaster gjennom fibroblastaktiveringsproteinhemmere (FAPI) i forskjellige tumortyper (FAPIDO)
The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of [18F]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Edegem, Belgia, 2650
- Har ikke rekruttert ennå
- University Hospital Antwerp (UZA)
-
Ta kontakt med:
- Sigrid Stroobants, Prof. Dr.
-
Hovedetterforsker:
- Sigrid Stroobants, Prof. Dr.
-
Ghent, Belgia, 9000
- Rekruttering
- University Hospital Ghent
-
Ta kontakt med:
- Karen Geboes, Prof. Dr.
- Telefonnummer: +32 9 332 05 30
- E-post: hiruz@uzgent.be
-
Hovedetterforsker:
- Karen Geboes, Prof. Dr.
-
Leuven, Belgia, 3000
- Rekruttering
- UZ Leuven
-
Ta kontakt med:
- Christophe Deroose, Prof. Dr.
- Telefonnummer: +3216343715
- E-post: christophe.deroose@uzleuven.be
-
Hovedetterforsker:
- Christophe Deroose, Prof. Dr.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria OGA:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
- Patient underwent a [18F]FDG PET/CT.
- TNM classification: cT1-4N0-3M0
Inclusion Criteria PDAC:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
- Patient underwent a [18F]FDG PET/CT or conventional staging with CT or MRI.
- TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.
Inclusion Criteria Clinically challenging cohort:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- Histologic or cytologic proven diagnosis of a malignancy.
- Patient underwent a [18F]FDG PET/CT.
- Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.
Exclusion Criteria:
- Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
- Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
- Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
- Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Øsophagogastrisk adenokarsinom (OGA)
|
A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery. |
|
Eksperimentell: Pankreas duktalt adenokarsinom (PDAC)
|
A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery. |
|
Eksperimentell: Klinisk utfordrende situasjoner
|
A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Detection ratio for lymph node and distant metastases (combined). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Detection ratio for lymph node and distant metastases (combined). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Fraction of patients were scan was deemed contributory. This means:
|
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OGA & PDAC: Detection ratio for tumor detection
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
primary tumor alone; lymph nodes alone (N-staging); distant metastases alone (M-staging) and lymph node + distant metastases combined (with inclusion of patients without N- or M-lesions). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: specificity, positive and negative predictive value and accuracy
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Specificity, positive predictive value, negative predictive value, accuracy for lymph node and distant metastases (combined); for detection of primary tumor; for lymph nodes alone (N-staging); for distant metastases alone (M-staging). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Positive and negative likelihood ratios; diagnostic odds ratio. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: semi-quantitative uptake measurements
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: tumor-to-background uptake values
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Tumor-to-background uptake values (TBR; SUV lesion divided by SUV background) for [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: impact on TNM stage
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to full staging ([18F]FDG PET/CT and conventional imaging) and impact of [18F]AlF-FAPI-74 PET/CT compared to only conventional imaging-based staging. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: impact on clinical management
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Impact on clinical management. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: impact on potential radiation therapy plan
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Impact on potential radiation therapy plan. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: psychological impact
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Psychological impact on patient of [18F]AlF-FAPI-74 PET/CT procedure. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: reproducibility
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Intra- and interobserver reproducibility of both [18F]FDG and [18F]AlF-FAPI-74 PET/CT. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: adverse events
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Patient safety: adverse events of [18F]AlF-FAPI-74 PET/CT. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: evolution between baseline and end of neo-adjuvant treatment
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score;(v) treatment plan based on scan. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
OGA & PDAC: correlation with immunohistochemistry
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Correlation of [18F]AlF-FAPI-74 biodistribution with FAP tissue expression as measured by immunohistochemistry (IHC). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis OGA: lymph node detection
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced). Sensitivity, specificity, postivie predictive value, negative predictive value for lymph nodes. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis OGA: impact on TNM stage
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced). Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT-based stage. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced). Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis OGA: correlation with pathology
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced). Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis PDAC: tumor detection
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced). Subgroup 2: Metastatic patients. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy for lymph nodes and distant metastases. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis PDAC: impact on TNM stage
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced). Subgroup 2: Metastatic patients. Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT, CT or MRI-based stage. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced). Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis PDAC: correlation with pathology
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced). Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Subgroup analysis PDAC: association with survival
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Subgroup 2: Metastatic patients. Association between total tumor burden on [18F]AlF-FAPI-74 PET/CT and survival. Association between semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and survival. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: detection rate
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Primary tumor/local recurrence, lymph node and distant metastases detection rate (compared to best value comparator) vs. [18F]FDG PET/CT. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: semi-quantitative uptake measurements
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV. (SUVmean), peak SUV (SUVpeak)) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: tumor-to-background uptake values
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Tumor-to-background uptake values (SUV lesion divided by SUV background) on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake). |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: impact on potential radiation therapy plan
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Impact on potential radiation therapy plan of [18F]AlF-FAPI-74 PET/CT vs. [18F]FDG PET/CT. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: reproducibility
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Intra- and interobserver reproducibility. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
|
Clinically Challenging Situation: adverse events
Tidsramme: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Patient safety: adverse events. |
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S67792
- 2024-512059-19 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .