FAP-targeted PET and near-infrared fluorescence imaging for resectable non-small cell lung cancer

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

We are testing whether FAP-targeted PET and near-infrared fluorescence can help find residual tumor and guide surgery in people with stage II–IIIB resectable non-small cell lung cancer after neoadjuvant therapy.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07498933 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective diagnostic study in patients with stage II–IIIB resectable non-small cell lung cancer who have completed neoadjuvant therapy. Participants undergo preoperative FAP-targeted PET/CT and then fluorescence imaging with an EB-FAPI probe one week before surgery; intraoperative near-infrared fluorescence is used to help localize lesions. After resection, ex vivo fluorescence mapping and systematic multipoint sampling (tumor center, margin, adjacent normal tissue) are performed alongside routine pathological sampling and immunohistochemistry. The study compares the localization accuracy and concordance of PET and fluorescence signals with pathological gold standards and tests whether fluorescence-guided sampling reduces false-negative pathology and improves detection of residual tumor.

Who should consider this trial

Good fit: Adults aged 18–70 with biopsy-proven, resectable stage II–IIIB non-small cell lung cancer who have complete clinical and imaging data and have completed at least three cycles of neoadjuvant therapy are the ideal candidates.

Not a fit: Patients who have other concurrent malignancies, received prior anti-tumor treatments outside the protocol, have insufficient tumor tissue, poor-quality PET imaging, or who had fewer than three cycles of neoadjuvant therapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could make it easier for surgeons and pathologists to find residual tumor after neoadjuvant therapy, improving surgical guidance and pathological detection.

How similar studies have performed: FAP-targeted PET imaging has shown promising tumor detection in prior studies, but combining FAP-targeted PET with near-infrared fluorescence for intraoperative tumor bed delineation is novel and largely exploratory.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Hao Li, MD — Peking University People's Hospital
• Study coordinator: Kezhong Chen, MD

Conditions: Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy, PET Imaging, NIR Imaging