Using a new imaging technique to detect cancer-associated fibroblasts in various cancers

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

This study is testing a new imaging method to see if it can better detect certain cancer-related cells in people with newly diagnosed esophageal or pancreatic cancer compared to standard imaging techniques.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 109 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: KU Leuven (Academic / other)
• Drugs / interventions: radiation
• Locations: 3 sites (Edegem and 2 other locations)
• Trial ID: NCT06782412 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to validate the effectiveness of [18F]AlF-FAPI-74 PET/CT imaging in detecting cancer-associated fibroblasts in patients with newly diagnosed oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma. The study compares the detection rates of this new imaging method against the traditional [18F]FDG PET/CT and other conventional imaging techniques. Participants must have a confirmed diagnosis and specific TNM classifications for their cancer. The trial is designed to assess the clinical utility of this imaging approach in challenging oncological cases.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with newly diagnosed oesophagogastric or pancreatic ductal adenocarcinoma who have undergone prior imaging.

Not a fit: Patients with upfront resectable pancreatic ductal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved detection and management of certain types of cancer, enhancing patient outcomes.

How similar studies have performed: Other studies have shown promising results with similar imaging techniques, suggesting potential for success in this approach.

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.

Where this trial is running

Edegem and 2 other locations

• University Hospital Antwerp (UZA) — Edegem, Belgium (Not_yet_recruiting)
• University Hospital Ghent — Ghent, Belgium (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)

Conditions Oesophageal Cancer; Gastric Cancer; Pancreatic Ductal Adenocarcinoma; FAP; Oncology; Oncologic Disorders; Oesophagogastric adenocarcinoma; Pancreatic ductal adenocarcinoma