Clinical trial NCT06782412: Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Official title: Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Oesophageal Cancer
Gastric Cancer
Pancreatic Ductal Adenocarcinoma
FAP
Oncology
Oncologic Disorders
Keywords: Oesophagogastric adenocarcinoma
Pancreatic ductal adenocarcinoma
Clinically challenging situations
[18F]-FDG
[18F]-FAPI-74
[18F]AIF-FAPI-74
Positron emission tomography
PET
Nuclear imaging
Oncology
Prospective
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: University Hospital, Antwerp
name: Universitaire Ziekenhuizen KU Leuven
name: Kom Op Tegen Kanker
First posted: 2025-01-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial.

The three cohorts are: Oesophagogastric adenocarcinoma (OGA), pancreatic ductal adenocarcinoma (PDAC) and clinically challenging situations.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria OGA:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
4. Patient underwent a \[18F\]FDG PET/CT.
5. TNM classification: cT1-4N0-3M0

Inclusion Criteria PDAC:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
4. Patient underwent a \[18F\]FDG PET/CT or conventional staging with CT or MRI.
5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.

Inclusion Criteria Clinically challenging cohort:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. Histologic or cytologic proven diagnosis of a malignancy.
4. Patient underwent a \[18F\]FDG PET/CT.
5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion Criteria:

1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
4. 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).
5. 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.
6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
7. Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.

Primary outcomes:
measure: Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: 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)
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Secondary outcomes:
measure: OGA & PDAC: Detection ratio for tumor detection
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: specificity, positive and negative predictive value and accuracy
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: semi-quantitative uptake measurements
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: tumor-to-background uptake values
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: impact on TNM stage
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: impact on clinical management
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: impact on potential radiation therapy plan
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: psychological impact
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: reproducibility
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: adverse events
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: evolution between baseline and end of neo-adjuvant treatment
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: OGA & PDAC: correlation with immunohistochemistry
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis OGA: lymph node detection
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis OGA: impact on TNM stage
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis OGA: correlation with pathology
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis PDAC: tumor detection
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis PDAC: impact on TNM stage
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis PDAC: correlation with pathology
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Subgroup analysis PDAC: association with survival
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: detection rate
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: semi-quantitative uptake measurements
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: tumor-to-background uptake values
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: impact on potential radiation therapy plan
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: reproducibility
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
measure: Clinically Challenging Situation: adverse events
timeFrame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Gent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: