Clinical Applications of FAPI PET in Solid Tumors
2026年8月17日 更新者：Ruijin Hospital
Clinical Applications of Novel FAPI PET in Diverse Solid Tumors
The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
調査の概要
詳細な説明
This prospective study is designed to evaluate and compare the PET/CT or PET/MR imaging characteristics of two fibroblast activation protein (FAP)-targeted tracers-the novel tracer FAPI-RuiJ and the reference tracer FAPI-04-across a diverse range of solid tumors.
All enrolled patients will undergo paired PET imaging with both FAPI-RuiJ and FAPI-04.
For each tracer, semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, tumor-to-background ratio [TBR]）will be measured and compared.
Biodistribution characteristics of FAPI-RuiJ in normal organs will be assessed to determine its in vivo metabolic profile.
Using histopathology or imaging follow-up as the reference standard, the diagnostic performance of FAPI-RuiJ PET will be compared with that of FAPI-04 PET, with evaluation metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC).
Correlation analyses will be performed between PET parameters and clinicopathological characteristics, including tumor markers, pathological subtype, and immunohistochemical markers.The study is expected to provide a novel molecular imaging tool to support early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
研究の種類
介入
入学 (推定)
200
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：Ying Miao
- 電話番号：0086-13671921521
- メール：myada821@hotmail.com
研究場所
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Shanghai、中国
- 募集
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Ying Miao
- 電話番号：0086-13671921521
- メール：myada821@hotmail.com
-
-
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:
- Age ≥ 18 years and ≤ 80 years, regardless of gender.
- Participants with suspected, confirmed, or suspected recurrent solid tumors.
- Participants who agree to participate in this clinical trial and provide written informed consent.
- Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process.
- No plans for pregnancy within 6 months.
Exclusion Criteria:
- Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency.
- Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures.
- Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions.
- Pregnant or breastfeeding women.
- Patients with poor compliance.
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Participants will undergo FAPI-RuiJ PET/CT or PET/MR, followed by FAPI-04 imaging on a separate day
Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-RuiJ administered first and FAPI-04 on a separate day (interval: 1-7 days).
For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time.
All images will be independently reviewed by two blinded nuclear medicine physicians.
Histopathology or imaging follow-up serves as the reference standard.
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A novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
|
|
実験的：Participants will undergo FAPI-04 PET/CT or PET/MR, followed by FAPI-RuiJ imaging on a separate day
Participants will undergo paired PET/CT or PET/MR imaging sequentially, with FAPI-04 administered first and FAPI-RuiJ on a separate day (interval: 1-7 days).
For each tracer, a single intravenous injection will be given, followed by whole-body image acquisition at a standardized post-injection time.
All images will be independently reviewed by two blinded nuclear medicine physicians.
Histopathology or imaging follow-up serves as the reference standard.
|
A novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
|
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 sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET
時間枠：Through study completion, an average of 3 years
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Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.
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Through study completion, an average of 3 years
|
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AUC of FAPI-RuiJ PET versus FAPI-04 PET
時間枠：Through study completion, an average of 3 years
|
Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.
|
Through study completion, an average of 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
時間枠：At the time of PET/CT scan
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Semi-quantitative comparison of standardized uptake value (SUV) parameters (SUVmax, SUVmean, and SUVpeak) between the two tracers in solid tumor lesions.
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At the time of PET/CT scan
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Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
時間枠：At the time of PET/CT scan
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Semi-quantitative comparison of TBR between the two tracers in solid tumor lesions.
TBR is calculated as the ratio of tumor SUVmax to background SUVmean.
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At the time of PET/CT scan
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Biodistribution characteristics of FAPI-RuiJ PET in normal organs
時間枠：At the time of PET/CT scan
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Quantitative assessment of FAPI-RuiJ tracer biodistribution in major normal organs (including brain, submandibular gland, thyroid, lung, descending aorta, heart, liver, pancreas, stomach, spleen, kidney, bone, muscle, small intestine, gallbladder) measured by SUVmean and SUVmax on PET/CT images using ROI-based analysis.
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At the time of PET/CT scan
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Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors
時間枠：Through study completion, an average of 3 years
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Correlation analysis between FAPI-RuiJ PET semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, TBR and clinicopathological characteristics, including tumor markers (e.g., CEA, CA19-9, AFP, etc.), pathological subtype, and immunohistochemical markers (e.g., Ki-67, PD-L1, EGFR, etc.).
Correlations will be assessed using Spearman's rank correlation coefficient (ρ), with statistical significance set at p < 0.05.
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Through study completion, an average of 3 years
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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
捜査官
- 主任研究者：Biao Li、Ruijin Hospital
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 (実際)
2026年7月2日
一次修了 (推定)
2029年3月31日
研究の完了 (推定)
2029年3月31日
試験登録日
最初に提出
2026年7月26日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月20日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026 CER 311
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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