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Die klinische Studie NCT07498933 für Nicht-kleinzelliger Lungenkrebs, PET-CT, Neoadjuvante Therapie ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
FAP-targeted PET/NIR in Lung Malignant Tumors 200 Immuntherapie Kombinationstherapie
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07498933 ist eine beobachtungsstudie zur Untersuchung von Nicht-kleinzelliger Lungenkrebs, PET-CT, Neoadjuvante Therapie und hat den Status offene rekrutierung. Die Studie startete am 3. Juni 2025 und soll 200 Teilnehmer aufnehmen. Durchgeführt von Peking University People's Hospital ist der Abschluss für 31. Dezember 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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, ...Mehr anzeigen
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel
Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
Erkrankungen
Nicht-kleinzelliger LungenkrebsPET-CTNeoadjuvante TherapiePublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- 2101000672
NCT-Nummer
Studienbeginn (tatsächlich)
2025-06-03
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2027-12-31
Geplante Rekrutierung
200
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
PET Imaging
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
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...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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 HospitalVerantwortliche Partei
Chen KeZhong, Hauptprüfer, Director of Thoracic Oncology Institute, Peking University People's Hospital
Zentrale Studienkontakte
Kontakt: Kezhong Chen, MD, +86-010-88325983, [email protected]
Kontakt: Qingyun Liu, MD, [email protected]
1 Studienstandorte in 1 Ländern
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Kezhong Chen, MD, Kontakt, +86-010-88325983, [email protected]
Offene Rekrutierung