Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06782412
NCT06782412RecruitingPhase 2

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

KU Leuven3 sites in 1 country109 target enrollmentStarted: February 6, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
KU Leuven
Enrollment
109
Locations
3
Primary Endpoint
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Arms & Interventions

Pancreatic ductal adenocarcinoma (PDAC)

Experimental

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

Clinically challenging situations

Experimental

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

Oesophagogastric adenocarcinoma (OGA)

Experimental

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

Outcomes

Primary Outcomes

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)

Detection ratio for lymph node and distant metastases (combined).

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)

Detection ratio for lymph node and distant metastases (combined).

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)

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.

Secondary Outcomes

  • Clinically Challenging Situation: detection rate(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • 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))
  • OGA & PDAC: impact on TNM stage(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(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(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(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(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(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(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis OGA: lymph node 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: correlation with immunohistochemistry(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis OGA: impact on TNM stage(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis OGA: correlation with pathology(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis PDAC: tumor detection(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis PDAC: impact on TNM stage(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Subgroup analysis PDAC: correlation with pathology(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Clinically Challenging Situation: 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))
  • Subgroup analysis PDAC: association with survival(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Clinically Challenging Situation: 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))
  • Clinically Challenging Situation: impact on potential radiation therapy plan(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Clinically Challenging Situation: reproducibility(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))
  • Clinically Challenging Situation: adverse events(From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT))

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christophe Deroose, Prof. Dr.

Head of Clinic Nuclear Medicine, UZ Leuven - Full Professor, KU Leuven

KU Leuven

Study Sites (3)

Loading locations...

Similar Trials

Recruiting
Not Applicable
PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal CancerRectal Cancer
NCT06318234Xiao Chen32
Terminated
Phase 4
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate CancerStage IVB Prostate Cancer AJCC v8Metastatic Prostate Carcinoma
NCT04134208M.D. Anderson Cancer Center2
Recruiting
Phase 1
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain MetastasisBrain Metastases
NCT06055790University of Arizona20
Recruiting
Not Applicable
Evaluation Using FAPI-PET Targeting Cancer-associated FibroblastsNeoplasms
NCT05442151Tadashi Watabe200
Completed
Not Applicable
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical ProstatectomyAdenocarcinoma of the Prostate
NCT02523924Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins50