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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
109
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.
University Hospital Antwerp (UZA)
Edegem, Belgium
NOT_YET_RECRUITINGUniversity Hospital Ghent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGPrimary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Detection ratio for lymph node and distant metastases (combined).
Time frame: 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)
Detection ratio for lymph node and distant metastases (combined).
Time frame: 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.
Fraction of patients were scan was deemed contributory. This means: 1. \[18F\]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. \[18F\]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. \[18F\]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: Detection ratio for tumor detection
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).
Time frame: 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
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).
Time frame: 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.
Positive and negative likelihood ratios; diagnostic odds ratio.
Time frame: 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
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.
Time frame: 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
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).
Time frame: 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
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.
Time frame: 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
Impact on clinical management.
Time frame: 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
Impact on potential radiation therapy plan.
Time frame: 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
Psychological impact on patient of \[18F\]AlF-FAPI-74 PET/CT procedure.
Time frame: 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
Intra- and interobserver reproducibility of both \[18F\]FDG and \[18F\]AlF-FAPI-74 PET/CT.
Time frame: 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
Patient safety: adverse events of \[18F\]AlF-FAPI-74 PET/CT.
Time frame: 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
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.
Time frame: 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
Correlation of \[18F\]AlF-FAPI-74 biodistribution with FAP tissue expression as measured by immunohistochemistry (IHC).
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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
Time frame: 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
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).
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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
Time frame: 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
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).
Time frame: 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
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.
Time frame: 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
Primary tumor/local recurrence, lymph node and distant metastases detection rate (compared to best value comparator) vs. \[18F\]FDG PET/CT.
Time frame: 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
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
Time frame: 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
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).
Time frame: 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
Impact on potential radiation therapy plan of \[18F\]AlF-FAPI-74 PET/CT vs. \[18F\]FDG PET/CT.
Time frame: 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
Intra- and interobserver reproducibility.
Time frame: 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
Patient safety: adverse events.
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
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