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

Обзор

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.

Вмешательства

• Диагностический тест [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

Первичные конечные точки

• Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT. [Срок оценки: 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) [Срок оценки: 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. [Срок оценки: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)]

Вторичные конечные точки (12)

• OGA & PDAC: Detection ratio for tumor detection [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 3 центра

• University Hospital Antwerp (UZA) — Edegem
• University Hospital Ghent — Ghent
• UZ Leuven — Leuven

Идентификаторы

NCT: NCT06782412 · S67792 · 2024-512059-19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗