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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

770

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • スイス
    • Canton of Aargau
      • Baden、Canton of Aargau、スイス
        • Kantonsspital Baden
        • コンタクト：
          • Irene Burger, Prof. Dr. med.
          • 電話番号：0041 56 486 38 80
          • メール：irene.burger@ksb.ch
        • 主任研究者：
          • Irene Burger, Prof. Dr. med.
    • Canton of Geneva
      • Geneva、Canton of Geneva、スイス
        • Hopitaux Universitaires de Geneve (HUG)
        • コンタクト：
        • 主任研究者：
          • Ismini Mainta, Dr. med.
    • Canton of Lucerne
      • Lucerne、Canton of Lucerne、スイス
        • Luzerner Kantonsspital
        • コンタクト：
        • 主任研究者：
          • Klaus Strobel, Prof. Dr. med.
    • Canton of Vaud
      • Genolier、Canton of Vaud、スイス
        • Clinique de Genolier
        • コンタクト：
        • 主任研究者：
          • Antoine Leimgruber, Dr. med.
    • Canton of Zurich
      • Zurich、Canton of Zurich、スイス、8091
        • Department for Nuclear Medicine, University Hospital Zurich
        • コンタクト：
        • 主任研究者：
          • Martin Hüllner, Prof. Dr. med.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：診断
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：[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.
薬：[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.
他の名前：
  • FAPI PET

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diagnostic Interpretability and Uptake Classification of [18F]FAPI-74 PET Imaging
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Lesion-Wise Comparison of [18F]FAPI-74 Uptake with Standard-of-Care Reference Imaging
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Martin Huellner

協力者

University Hospital, Zürich

捜査官

  • 主任研究者：Martin Hüllner, Prof. Dr. med.、Department for Nuclear Medicine, University Hospital Zurich

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2029年9月1日

研究の完了 (推定)

2029年9月1日

試験登録日

最初に提出

2026年7月1日

QC基準を満たした最初の提出物

2026年7月9日

最初の投稿 (実際)

2026年7月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月15日

QC基準を満たした最後の更新が送信されました

2026年7月9日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BASEC 2026-OO454 (その他の識別子：swissethics)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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