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临床试验/NCT06782412
NCT06782412招募中2 期

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 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2025年2月6日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
KU Leuven
入组人数
109
试验地点
3
主要终点
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Pancreatic ductal adenocarcinoma (PDAC)

Experimental

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

Clinically challenging situations

Experimental

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

Oesophagogastric adenocarcinoma (OGA)

Experimental

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

结局指标

主要结局

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

时间窗: 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)

时间窗: 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.

时间窗: 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.

次要结局

  • 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))

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christophe Deroose, Prof. Dr.

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

KU Leuven

研究点 (3)

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