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Recruiting 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

Phase II / Phase III Interventional Oesophageal Cancer Gastric Cancer Pancreatic Ductal Adenocarcinoma FAP

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]AlF-FAPI-74 PET/CT.
Who it may be relevant to
Registry conditions: Oesophageal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma, FAP. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test [18F]AlF-FAPI-74 PET/CT
    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 advers

Primary outcome measures

  • Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [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)]
  • 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) [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. [Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)]
Secondary outcome measures (12)
  • OGA & PDAC: Detection ratio for tumor detection [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 [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. [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 [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 [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 [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 [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 [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 [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 [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 [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 [Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 3 centers
  • University Hospital Antwerp (UZA) — Edegem
  • University Hospital Ghent — Ghent
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06782412 · S67792 · 2024-512059-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗