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

NCT06782412 | Recruiting Phase 2

• 2 other identifiers: S677922024-512059-19
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (3)

• Primary 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).

  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).

  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.

  From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Secondary Outcomes (28)

• OGA & PDAC: Detection ratio for tumor detection

  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

  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.

  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

  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

  From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Study Arms (3)

Oesophagogastric adenocarcinoma (OGA)

EXPERIMENTAL

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

Pancreatic ductal adenocarcinoma (PDAC)

EXPERIMENTAL

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

Clinically challenging situations

EXPERIMENTAL

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

Interventions

[18F]AlF-FAPI-74 PET/CT DIAGNOSTIC_TEST

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.

Clinically challenging situations; Oesophagogastric adenocarcinoma (OGA); Pancreatic ductal adenocarcinoma (PDAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• University Hospital, Ghent: collaborator
• University Hospital, Antwerp: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Kom Op Tegen Kanker: collaborator

Study Sites (3)

University Hospital Antwerp (UZA)

Edegem, 2650, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic Nuclear Medicine, UZ Leuven - Full Professor, KU Leuven

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)