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RECRUITING
NCT07498933

FAP-targeted PET/NIR in Lung Malignant Tumors

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

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, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET/fluorescence were compared and analyzed.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-06-03

Completion Date

2027-12-31

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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 correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China