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El ensayo clínico NCT07498933 para Cáncer de pulmón de células no pequeñas, PET-TC, Terapia neoadyuvante está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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FAP-targeted PET/NIR in Lung Malignant Tumors 200 Inmunoterapia Terapia combinada

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07498933 es un estudio observacional para Cáncer de pulmón de células no pequeñas, PET-TC, Terapia neoadyuvante. Su estado actual es: reclutando. El estudio se inició el 3 de junio de 2025, con el objetivo de reclutar a 200 participantes. Dirigido por Peking University People's Hospital, se espera que finalice el 31 de diciembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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, ...Mostrar más
Descripción detallada
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...Mostrar más
Título oficial

Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation

Condiciones médicas
Cáncer de pulmón de células no pequeñasPET-TCTerapia neoadyuvante
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • 2101000672
Número del NCT
NCT07498933
Inicio del estudio (real)
2025-06-03
Última actualización
2026-03-27
Fecha de finalización (estimada)
2027-12-31
Inscripción (prevista)
200
Tipo de estudio
Observacional
Estado general
Reclutando
Palabras clave
PET Imaging
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
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...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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)
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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 logoPeking University People's Hospital
Parte responsable del estudio
Chen KeZhong, Investigador principal, Director of Thoracic Oncology Institute, Peking University People's Hospital
Contactos centrales del estudio
Contacto: Kezhong Chen, MD, +86-010-88325983, [email protected]
Contacto: Qingyun Liu, MD, [email protected]
1 Centros del estudio en 1 países

Beijing Municipality

Peking University People's Hospital, Beijing, Beijing Municipality, China
Kezhong Chen, MD, Contacto, +86-010-88325983, [email protected]
Reclutando