RecruitingNCT07498933

FAP-targeted PET/NIR in Lung Malignant Tumors

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


Sponsor

Peking University People's Hospital

Enrollment

200 participants

Start Date

Jun 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • Age between 18 and 70 years old;
  • Have complete clinical and imaging data;
  • Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer;
  • Able to retain sufficient tumor tissue for testing and research;
  • Sign informed consent.

Exclusion Criteria6

  • Previously combined with other malignant tumors or received other anti-tumor treatments;
  • Failure to collect sufficient tumor tissue for testing and research;
  • The duration of neoadjuvant therapy is less than 3 cycles;
  • The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing;
  • Lack of clinical and imaging data;
  • There are situations where other researchers consider it inappropriate to participate in this study

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Interventions

DIAGNOSTIC_TESTPET/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

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NCT07498933


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