Trial Radar IA | ||
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Lo studio clinico NCT07498933 per Carcinoma polmonare non a piccole cellule, PET-TC, Terapia neoadiuvante è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Vista a schede
FAP-targeted PET/NIR in Lung Malignant Tumors 200 Immunoterapia Terapia combinata
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07498933 è uno studio osservazionale per Carcinoma polmonare non a piccole cellule, PET-TC, Terapia neoadiuvante, attualmente in arruolamento. Avviato il 3 giugno 2025, prevede di arruolare 200 partecipanti. Sotto la guida di Peking University People's Hospital, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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, ...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale
Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
Patologie
Carcinoma polmonare non a piccole cellulePET-TCTerapia neoadiuvantePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- 2101000672
Numero NCT
Data di inizio (effettiva)
2025-06-03
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
200
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
PET Imaging
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
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...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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) |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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 HospitalParte responsabile dello studio
Chen KeZhong, Investigatore principale, Director of Thoracic Oncology Institute, Peking University People's Hospital
Contatti principali dello studio
Contatto: Kezhong Chen, MD, +86-010-88325983, [email protected]
Contatto: Qingyun Liu, MD, [email protected]
1 Centri dello studio in 1 paesi
Beijing Municipality
Peking University People's Hospital, Beijing, Beijing Municipality, China
Kezhong Chen, MD, Contatto, +86-010-88325983, [email protected]
In arruolamento