Overview
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.
Description
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 stromal regions. Surgical resection will be performed according to standard clinical practice. Immediately after tumor resection, ex vivo fluorescence imaging of the surgical specimen will be conducted using a EB-FAPI fluorescence probe. Based on fluorescence signal distribution, systematic multipoint sampling will be performed across tumor center, tumor margin, and adjacent normal tissues. Routine pathological sampling will be conducted in parallel according to standard protocols. Additional fluorescence-guided sampling will be performed in regions with persistent fluorescence signals. Histopathological analysis will be used as the reference standard to evaluate tumor bed distribution, residual tumor presence, and pathological response. The concordance between fluorescence imaging, PET imaging, and pathological findings will be analyzed. The study will also evaluate whether fluorescence-guided sampling can improve detection of residual tumor and reduce false-negative pathological assessments. This study aims to establish a multimodal imaging approach integrating preoperative molecular imaging and intraoperative fluorescence guidance to enhance tumor bed visualization and improve the accuracy of pathological response assessment after neoadjuvant therapy in NSCLC.
Eligibility
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
