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治験 NCT07498933（対象：非小細胞肺癌、PET-CT、術前補助療法）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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FAP-targeted PET/NIR in Lung Malignant Tumors 200 免疫療法 併用療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07498933 は 観察研究 臨床試験 で、非小細胞肺癌、PET-CT、術前補助療法 に関するものです。現在は 募集中 で、2025年6月3日 から開始しています。200 名の参加者 の募集が計画されています。この試験は Peking University People's Hospital によって主導され、2027年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, ...もっと見る
詳細説明
This is a prospective, exploratory clinical study designed to evaluate the role of FAP-targeted imaging in efficacy prediction and tumor bed delineation in patients with NSCLC undergoing surgical resection after neoadjuvant therapy. Following neoadjuvant treatment, enrolled patients will undergo preoperative FAP-targeted PET imaging to assess treatment response and identify metabolically active tumor-associated strom...もっと見る
公式タイトル
Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
疾患名
非小細胞肺癌PET-CT術前補助療法刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- 2101000672
NCT番号
開始日
2025-06-03
最終更新日
2026-03-27
終了予定日
2027-12-31
目標参加者数
200
試験の種類
観察研究
状況
募集中
キーワード
PET Imaging
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
FAP-targeted PET in lung malignant tumors Participant who conforms to the inclusion criteria will undergo 68Ga-FAPI/EB-FAPI PET/CT scans within 1 week. | PET/CT scans PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter c...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy | To evaluate the accuracy of intraoperative FAP-targeted fluorescence imaging in identifying the tumor bed after neoadjuvant therapy in NSCLC patients, using histopathological assessment as the reference standard. Tumor bed regions identified by fluorescence will be compared with pathological mapping of tumor, regression bed, and residual tumor distribution. | From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery) |
Diagnostic performance of preoperative FAPI PET for treatment response assessment | To evaluate the ability of preoperative FAPI PET imaging to predict pathological response after neoadjuvant therapy, using pathological response (pCR/MPR/non-MPR) as the reference standard. | From preoperative imaging to postoperative pathological assessment (within 4 weeks) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Correlation between fluorescence signal intensity and pathological features | To evaluate the correlation between fluorescence signal intensity and pathological parameters, including tumor cell density, regression bed, and FAP expression (e.g., immunohistochemistry), across tumor (T), margin (M), and normal (N) regions. | Postoperative specimen analysis (within 2-3 weeks after surgery) |
Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens | To quantify fluorescence signal contrast between tumor, tumor margin, and normal tissues, and determine optimal thresholds for tumor bed delineation. | Postoperative specimen analysis (within 2-3 weeks after surgery) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 1. Age between 18 and 70 years old; 2. Have complete clinical and imaging data; 3. Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer; 4. Able to retain sufficient tumor tissue for testing and research; 5. Sign informed consent.
- 1. Previously combined with other malignant tumors or received other anti-tumor treatments; 2. Failure to collect sufficient tumor tissue for testing and research; 3. The duration of neoadjuvant therapy is less than 3 cycles; 4. The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing; 5. Lack of clinical and imaging data; 6. There are situations where other researchers consider it inappropriate to participate in this study
Peking University People's Hospital責任者
Chen KeZhong, 主任研究者, Director of Thoracic Oncology Institute, Peking University People's Hospital
試験中央連絡先
連絡先: Kezhong Chen, MD, +86-010-88325983, [email protected]
連絡先: Qingyun Liu, MD, [email protected]
1 1カ国の場所
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Kezhong Chen, MD, 連絡先, +86-010-88325983, [email protected]
募集中