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FAPI PET Imaging - An Exploratory Study (FAPIPET)

2026年7月9日 更新者：Martin Huellner

FAPI PET Imaging - a Multicentric Exploratory Evaluation

This study is testing a new imaging tracer called [18F]FAPI-74 with PET scans. Researchers want to find out how well this tracer shows certain diseases in the body, including several types of cancer and some non-cancer conditions like fibrosis and sarcoidosis.

[18F]FAPI-74 attaches to a protein found on cells that are active in tumors and areas of scarring or inflammation. This may help doctors see these areas more clearly than with imaging methods used today, especially in diseases where current scans do not work well.

People who join this study will get one injection of the tracer into a vein, then have one PET/CT or PET/MR scan. This takes about 2 hours in total. Researchers will compare the results with imaging the participant already had as part of their regular care, such as other PET scans, CT, or MRI. No extra treatment is given, and no other visits are needed.

The study will take place at 5 hospitals in Switzerland and plans to include about 770 adults with a confirmed or suspected diagnosis of one of the conditions being studied. The main goal is to see how clearly the tracer shows up on the scan. Researchers will also look at whether this new scan changes how confident doctors feel about a diagnosis, or changes the patient's treatment plan.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background and Rationale:

Fibroblast Activation Protein (FAP) is highly expressed in cancer-associated fibroblasts and in a range of fibrotic and inflammatory diseases. [18F]FAPI-74 is a novel PET radiotracer that binds selectively to FAP, enabling visualization of fibroblast activity. Early clinical studies have demonstrated promising tumour-to-background contrast, superior detectability compared with FDG in several tumours, and potential value in diseases where no adequate PET tracers exist. This multicentre study aims to systematically evaluate biodistribution, uptake patterns, and diagnostic usefulness of [18F]FAPI-74 across a broad spectrum of oncologic and non-oncologic indications.

Study Design:

This is an open-label, non-randomized, single-arm, exploratory diagnostic study conducted at five Swiss centres. Each participant undergoes a single administration of [18F]FAPI-74 followed by one PET/CT or PET/MR scan. No therapeutic interventions, follow-up visits, or repeat tracer administrations are planned. Standard-of-care imaging (e.g., FDG-PET/CT, PSMA-PET/CT, CT or MRI) already available for each participant is used as the reference for intra-individual comparison. The total radiation dose is approximately 7 mSv (≈3.5 mSv PET + ≈3.5 mSv low-dose CT), comparable to standard clinical PET/CT exposure.

Population:

Approximately 770 participants (age ≥18) will be recruited consecutively across 17 indication-specific subgroups: thyroid pathology; head and neck cancer (including cancer of unknown primary); neck node metastases from cancer of unknown primary; sinonasal tract tumor; sarcoidosis; thyroid cancer (suspected recurrence/persistence); breast cancer; hepatocellular carcinoma; gastric cancer; pancreatic cancer; prostate cancer (biochemical recurrence with negative PSMA-PET); urothelial carcinoma; multiple myeloma/plasmocytoma; mesothelioma; hepatic fibrosis; endometriosis; and lung fibrosis. Full eligibility criteria and per-indication enrollment targets are provided in the Eligibility Criteria module.

Investigational Medicinal Product:

[18F]FAPI-74 is a fluorine-18-labelled small-molecule inhibitor targeting FAP. Administered activity is approximately 250 MBq, with a permissible site-specific range of 200-300 MBq. Route of administration is intravenous slow bolus injection (5-15 seconds). The product is manufactured at the USZ Radiopharmacy under GMP conditions, using precursor material supplied by SOFIE Biosciences. Imaging is performed 45-60 minutes post-injection.

Procedures:

Screening includes eligibility assessment, informed consent, collection of demographic and clinical information, and review of historical imaging. Study Visit (Day 0) includes reconfirmation of eligibility, radiotracer injection, a 45-60 minute uptake phase, PET/CT or PET/MR acquisition, adverse event assessment, and discharge. This is a single-visit study; no follow-up visits are planned.

Outcomes:

Primary and secondary outcome definitions, including uptake classification, image quality rating, and comparison methodology against reference imaging, are provided in full in the Outcome Measures module.

Statistical Methods:

The study is descriptive and exploratory in nature. No hypothesis-driven power calculation was performed; sample size was determined based on prior experience with comparable diagnostic imaging studies, published literature, and feasibility considerations.

Quality Assurance:

Monitoring is performed by the Clinical Trials Center (CTC), University Hospital Zurich, in accordance with ICH-GCP and the Swiss Ordinance on Clinical Trials (ClinO). Study data are collected in REDCap® and pseudonymised; imaging data remain stored in institutional PACS systems under standard institutional access controls.

Funding and Insurance:

Each participating centre covers its own operational costs. Precursor material for [18F]FAPI-74 is supplied by SOFIE Biosciences under contractual agreement. Insurance coverage is provided through the Sponsor-Investigator's institutional policy (Baloise Versicherung AG), in accordance with ClinO Annex 2.

研究类型

介入性

注册 (估计的)

770

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞士
    • Canton of Aargau
      • Baden、Canton of Aargau、瑞士
        • Kantonsspital Baden
        • 接触：
        • 首席研究员：
          • Irene Burger, Prof. Dr. med.
    • Canton of Geneva
      • Geneva、Canton of Geneva、瑞士
        • Hopitaux Universitaires de Geneve (HUG)
        • 接触：
        • 首席研究员：
          • Ismini Mainta, Dr. med.
    • Canton of Lucerne
      • Lucerne、Canton of Lucerne、瑞士
        • Luzerner Kantonsspital
        • 接触：
        • 首席研究员：
          • Klaus Strobel, Prof. Dr. med.
    • Canton of Vaud
      • Genolier、Canton of Vaud、瑞士
        • Clinique de Genolier
        • 接触：
        • 首席研究员：
          • Antoine Leimgruber, Dr. med.
    • Canton of Zurich
      • Zurich、Canton of Zurich、瑞士、8091
        • Department for Nuclear Medicine, University Hospital Zurich
        • 接触：
        • 首席研究员：
          • Martin Hüllner, Prof. Dr. med.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Written informed consent obtained and documented by the participant's signature.
  • Age ≥18 years at the time of consent.
  • Clinically established or suspected diagnosis or recurrence of an oncologic or non-oncologic disease as defined in chapter 7.1 of study protocol.
  • Availability of standard-of-care imaging (e.g., clinically established PET tracer or anatomical imaging such as CT/MRI) to allow comparative evaluation.

Exclusion Criteria:

  • Severe claustrophobia that would preclude PET imaging.
  • Inability to remain still for the duration of the PET/MR examination.
  • Current pregnancy or breastfeeding; no pregnancy test is required for women who are postmenopausal for ≥12 months or have undergone surgical sterilization, bilateral oophorectomy, or hysterectomy.
  • Previous hypersensitivity reactions to radiotracer administration
  • Inability to understand the study information, for example due to language barriers.
  • Subjects incapable of judgment (e.g. individuals under legal or medical incapacity).
  • Participants scheduled for PET/MR imaging: Presence of MRI-incompatible metallic implants, electronic devices (e.g. pacemakers, cochlear implants), or other ferromagnetic foreign bodies.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：[18F]FAPI-74 PET Imaging
Participants receive a single intravenous injection of approximately 250 MBq [18F]FAPI-74 (fluorine-18 labelled FAP-targeted PET radiotracer), followed by one PET/CT or PET/MR scan performed 45-60 minutes post-injection. For PET/CT acquisitions, a low-dose CT is performed for attenuation correction and anatomical localization. No therapeutic intervention, randomization, or repeat tracer administration is involved. Uptake and diagnostic image quality are assessed qualitatively by a nuclear medicine physician from the local study team. Findings are compared with each participant's own previously acquired standard-of-care imaging (e.g., FDG-PET/CT, PSMA-PET/CT, CT, or MRI), which serves as the reference standard rather than a concurrent study arm. Total participation time is approximately 2 hours on a single study day.
药品：[18F]FAPI-74 PET/CT
18F]FAPI-74 is a fluorine-18 labelled, quinoline-based small-molecule inhibitor targeting fibroblast activation protein (FAP), a transmembrane glycoprotein selectively expressed on cancer-associated fibroblasts and in fibrotic/inflammatory tissue. Each participant receives a single intravenous slow-bolus injection (5-15 seconds) of approximately 250 MBq (permissible range 200-300 MBq), followed by a 45-60 minute uptake period and one PET/CT or PET/MR acquisition. The product is manufactured under GMP at the USZ Radiopharmacy using precursor material supplied by SOFIE Biosciences. Unlike clinically established PET tracers (e.g., FDG, PSMA-ligands), [18F]FAPI-74 is not yet authorized in Switzerland and is administered exclusively within this investigational protocol for diagnostic evaluation purposes only.
其他名称：
  • FAPI PET

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging
大体时间：At the time of [18F]FAPI-74 PET/CT or PET/MR image acquisition and interpretation, performed 45-60 minutes after tracer injection, on the single study visit day.
Qualitative assessment of [18F]FAPI-74 uptake by a local nuclear medicine physician, classified as FAPI-positive or FAPI-negative in target lesions or disease-specific regions. Overall diagnostic image quality will additionally be rated using a 4-point scale: fully diagnostic, almost fully diagnostic, diagnostically limited, or non-diagnostic. The primary analysis will report the proportion of participants with diagnostically interpretable [18F]FAPI-74 images, per indication and pooled across indications.
At the time of [18F]FAPI-74 PET/CT or PET/MR image acquisition and interpretation, performed 45-60 minutes after tracer injection, on the single study visit day.

次要结果测量

结果测量
措施说明
大体时间
Lesion-Wise Comparison of [18F]FAPI-74 Uptake with Standard-of-Care Reference Imaging
大体时间：At the time of [18F]FAPI-74 image interpretation, compared against each participant's most recent standard-of-care reference imaging obtained as part of routine clinical care
Qualitative and semi-quantitative comparison of [18F]FAPI-74 uptake with each participant's available standard-of-care reference imaging (e.g., FDG-PET/CT, PSMA-PET/CT, or morphological imaging such as CT/MRI), performed on a lesion-wise basis. Comparative ratings will classify [18F]FAPI-74 findings as providing more, comparable, or less diagnostic information relative to the reference imaging. Where available, histopathology or composite clinical/imaging follow-up will serve as the reference standard for calculating sensitivity, specificity, and positive predictive value per indication.
At the time of [18F]FAPI-74 image interpretation, compared against each participant's most recent standard-of-care reference imaging obtained as part of routine clinical care
Change in Diagnostic Confidence and Clinical Management Following [18F]FAPI-74 Imaging
大体时间：Diagnostic confidence and management recommendations assessed immediately before and after review of [18F]FAPI-74 imaging, on the single study visit day.
Change in diagnostic confidence and clinical management recommendations, determined by comparing physician assessments performed before versus after review of [18F]FAPI-74 imaging. Diagnostic confidence will be rated on a defined scale; management change will be recorded as a binary indicator (yes/no), with the type of change categorized (e.g., additional biopsy recommended, therapy switch, change in staging). Clinical impact of [18F]FAPI-74 findings will additionally be classified as major impact (change in diagnosis or management), minor impact (additional findings not altering management), or no impact.
Diagnostic confidence and management recommendations assessed immediately before and after review of [18F]FAPI-74 imaging, on the single study visit day.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Martin Huellner

合作者

University Hospital, Zürich

调查人员

  • 首席研究员：Martin Hüllner, Prof. Dr. med.、Department for Nuclear Medicine, University Hospital Zurich

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2029年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BASEC 2026-OO454 (其他标识符：swissethics)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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