A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis (FOL-CARD)
2026年9月9日 更新者：Turku University Hospital
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis (FOL-CARD)
The goal of this prospective diagnostic study is to evaluate the imaging characteristics, diagnostic performance, radiation dosimetry, and safety of Al[¹⁸F]F-NOTA-folate PET imaging in patients with suspected cardiac sarcoidosis and infective endocarditis, and healthy volunteers. The study is non-interventional with respect to clinical management, and all diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
The main aims are to evaluate quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET imaging in the left ventricular myocardium of patients with suspected cardiac sarcoidosis, and in cardiac valves or prosthetic valve regions in patients with suspected infective endocarditis.
Participants will undergo PET imaging with Al[¹⁸F]F-NOTA-folate tracer at the Turku PET Centre. Participants with suspected cardiac sarcoidosis will undergo a second PET imaging study after initiation of immunosuppressive therapy.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
143
段階
- 適用できない
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
- 名前：Antti Saraste, Professor
- 電話番号：00358 50 4499979
- メール：antti.saraste@utu.fi
研究連絡先のバックアップ
- 名前：Tuija Vasankari, MSc
- メール：tuija.vasankari@varha.fi
研究場所
-
-
-
Turku、フィンランド、20520
- Turku University Hospital
-
コンタクト：
- Sanna Laurila, MD PhD
- 電話番号：00358 50 459 0097
- メール：sanna.laurila@varha.fi
-
-
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
はい
説明
Inclusion Criteria:
- Ability to provide written informed consent
- Suspected cardiac sarcoidosis group: clinical suspicion of cardiac sarcoidosis requiring diagnostic evaluation, including cardiac magnetic resonance and/or [¹⁸F]FDG PET
- Suspected infective endocarditis group: clinical suspicion of native or prosthetic valve infective endocarditis requiring diagnostic evaluation
- Healthy volunteers group:
- Age above 50 and post-menopausal (women)
- No history of cardiovascular disease, systemic inflammatory disease, malignancy, and no active infection
Exclusion Criteria:
- Pregnancy or breastfeeding
- Known hypersensitivity to folate-based compounds or investigational medical product excipients
- Unwillingness or inability to use effective contraception during the study participation period, in participants of childbearing potential
- Severe renal impairment (CKD-EPI GFR <20ml/min)
- Clinically unstable condition that, in the opinion of the investigator, would make study imaging unsafe or not feasible (e.g., haemodynamic instability, decompensated heart failure, uncontrolled clinically significant arrhythmia, suspicion of acute coronary syndrome)
- Systemic immunosuppressive therapy for more than 7 days prior to baseline Al[18F]F-NOTA-folate PET imaging
- Inability to complete protocol-defined study procedures
- Women of childbearing potential must have a negative pregnancy test prior to tracer administration
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：非ランダム化
- 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：Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis.
All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
|
Imaging is performed in all study groups to assess myocardial, valvular, and extracardiac tracer uptake using a total-body PET/CT system (Siemens Quadra, Siemens Healthcare, Erlangen, Germany).
Imaging will cover the region from head to mid-thighs to enable assessment of both cardiac and extracardiac tracer uptake.
Serum and plasma samples, ECG and vital signs are collected during the imaging study visit.
他の名前：
Resting myocardial perfusion imaging using [15O]water PET is performed only in patients with suspected cardiac sarcoidosis to assess myocardial perfusion and support interpretation of Al[18F]F-NOTA-folate uptake.
Transthoracic echocardiography (GE Vivid 95, GE Healthcare, Hjorten, Norway) will be performed in patients with suspected cardiac sarcoidosis to assess left ventricular structure and function.
Acquisition and analysis will follow standard clinical protocols.
Echocardiography will be performed during the same visits as PET imaging.
|
|
実験的：Suspected infective endocarditis
Patients with suspected infective endocarditis.
All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
|
Imaging is performed in all study groups to assess myocardial, valvular, and extracardiac tracer uptake using a total-body PET/CT system (Siemens Quadra, Siemens Healthcare, Erlangen, Germany).
Imaging will cover the region from head to mid-thighs to enable assessment of both cardiac and extracardiac tracer uptake.
Serum and plasma samples, ECG and vital signs are collected during the imaging study visit.
他の名前：
|
|
実験的：Healthy volunteers
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
|
Imaging is performed in all study groups to assess myocardial, valvular, and extracardiac tracer uptake using a total-body PET/CT system (Siemens Quadra, Siemens Healthcare, Erlangen, Germany).
Imaging will cover the region from head to mid-thighs to enable assessment of both cardiac and extracardiac tracer uptake.
Serum and plasma samples, ECG and vital signs are collected during the imaging study visit.
他の名前：
|
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 |
|---|---|---|
|
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
時間枠：Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.
|
Quantitative uptake of Al[¹⁸F]F-NOTA-folate on PET in the left ventricular myocardium (global and regional standardized uptake value (SUV) measures derived from polar map analysis) in suspected cardiac sarcoidosis.
|
Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.
|
|
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in infected versus non-infected cardiac valves or prostheses in patients with suspected infective endocarditis
時間枠：Visit 2 (baseline imaging), performed within 14 days of enrolment and no later than 14 days after initiation of intravenous antibiotic therapy.
|
Quantitative uptake of Al[¹⁸F]F-NOTA-folate on PET in the valve/prosthesis region in suspected infective endocarditis (SUVmax and TBR = SUVmax valve/prosthesis / SUVmean blood pool).
|
Visit 2 (baseline imaging), performed within 14 days of enrolment and no later than 14 days after initiation of intravenous antibiotic therapy.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
時間枠：From enrollment to study completion at 2 years.
|
From enrollment to study completion at 2 years.
|
|
|
Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
時間枠：From Visit 2 (baseline imaging) to Visit 3 (follow-up imaging). Visit 2 is performed 7 days after initiation of systemic immunosuppressive therapy and Visit 3 is performed approximately 3 months after baseline imaging.
|
Patients with confirmed CS may undergo optional follow-up static PET imaging with Al[¹⁸F]F-NOTA-folate and [¹⁵O]water approximately 3 months after baseline imaging to assess changes in inflammatory activity following initiation of immunosuppressive therapy.
|
From Visit 2 (baseline imaging) to Visit 3 (follow-up imaging). Visit 2 is performed 7 days after initiation of systemic immunosuppressive therapy and Visit 3 is performed approximately 3 months after baseline imaging.
|
|
Biodistribution and radiation dosimetry of Al[¹⁸F]F-NOTA-folate
時間枠：Visit 2 (imaging), performed 7-14 days after Visit 1 (screening and enrolment).
|
Healthy volunteers will undergo extended imaging, including dynamic imaging for 120 min starting at the time of tracer injection + static imaging for 10 minutes at 150 min after tracer injection to support analysis of tracer kinetics and biodistribution, and radiation dosimetry calculations.
|
Visit 2 (imaging), performed 7-14 days after Visit 1 (screening and enrolment).
|
|
Incidence and severity of adverse events related to Al[¹⁸F]F-NOTA-folate
時間枠：Suspected sarcoidosis and infective endocarditis groups: from Visit 2 (baseline imaging) to study completion at 2 years. Healthy volunteers: from Visit 2 to 48-72 hours, when safety laboratory tests will be obtained and AEs assessed by phone interview.
|
Incidence and severity of adverse events (AE) and adverse reactions; clinically significant changes in vital signs or ECG; changes in safety laboratory parameters (healthy volunteers); clinically indicated laboratory assessments performed in the event of an adverse event (as applicable); and investigator assessment of relationship to Al[¹⁸F]F-NOTA-folate.
|
Suspected sarcoidosis and infective endocarditis groups: from Visit 2 (baseline imaging) to study completion at 2 years. Healthy volunteers: from Visit 2 to 48-72 hours, when safety laboratory tests will be obtained and AEs assessed by phone interview.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Associations between myocardial Al[¹⁸F]F-NOTA-folate uptake and other parameters collected during study visits, and adverse cardiac events during follow-up in patients with suspected cardiac sarcoidosis.
時間枠：From enrollment to end of follow-up at 2 years.
|
Other measured parameters include left ventricular function, myocardial perfusion, and circulating and imaging biomarkers of myocardial injury or inflammation.
|
From enrollment to end of follow-up at 2 years.
|
|
Associations between valvular Al[¹⁸F]F-NOTA-folate uptake and clinical events in patients with suspected infective endocarditis.
時間枠：From study enrollment to end of follow-up at 2 years.
|
Clinical events include duration of antibiotic therapy, causative micro-organism, systemic inflammatory parameters, anatomical valvular lesions, need for cardiac surgery and adverse cardiac events during follow-up.
|
From study enrollment to end of follow-up at 2 years.
|
|
Extra-cardiac inflammatory or infectious foci.
時間枠：Suspected sarcoidosis group: Visit 2 (baseline imaging, for details see primary outcome measure) and Visit 3 (follow-up imaging after 3 months). Suspected infective endocarditis group: Visit 2 (baseline imaging, for details see primary outcome measure).
|
Detection and characterisation of extra-cardiac inflammatory or infectious foci on whole-body Al[¹⁸F]F-NOTA-folate PET imaging.
|
Suspected sarcoidosis group: Visit 2 (baseline imaging, for details see primary outcome measure) and Visit 3 (follow-up imaging after 3 months). Suspected infective endocarditis group: Visit 2 (baseline imaging, for details see primary outcome measure).
|
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。
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9月14日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年8月7日
QC基準を満たした最初の提出物
2026年9月9日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 13119
- 2026-526655-59-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。