RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: [18F]AlF-FAPI-74 PET/CT for Oesophageal Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT06782412 · KU Leuven · enrollment listed as 109

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are [18F]AlF-FAPI-74 PET/CT. The registry lists allocation as randomized. 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.

They plan to enroll about 109 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: [18F]AlF-FAPI-74 PET/CT

Primary outcome (registry wording): Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.

Who it is for (from inclusion criteria)

Ages 18 Years to any
New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma
Patient underwent a \[18F\]FDG PET/CT
TNM classification: cT1-4N0-3M0
who can join PDAC:
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

Who the registry excludes

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
Participation in an treatment 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

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

3 listed

University Hospital Antwerp (UZA) — Edegem, Belgium (not_yet_recruiting)
University Hospital Ghent — Ghent, Belgium (recruiting)
UZ Leuven — Leuven, Belgium (recruiting)

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FAQ about this NCT record

Is NCT06782412 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06782412?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06782412?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary