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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT scans | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezhong Chen, MD | Contact | +86-010-88325983 | mdkzchen@163.com | |
| Qingyun Liu, MD | Contact | +8615165620919 | qingyun_liu919@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kezhong Chen, MD | Peking University People's Hospital | Study Director |
| Jun Wang, M.M. | Peking University People's Hospital | Study Chair |
| Hao Li, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 37683638 | Background | Chen K, Yang F, Shen H, Wang C, Li X, Chervova O, Wu S, Qiu F, Peng D, Zhu X, Chuai S, Beck S, Kanu N, Carbone D, Zhang Z, Wang J. Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer. Cancer Cell. 2023 Oct 9;41(10):1749-1762.e6. doi: 10.1016/j.ccell.2023.08.010. Epub 2023 Sep 7. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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tissue
|
| 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) |
| Peking University People's Hospital |
| Principal Investigator |
| Yuan Li, MD | Peking University People's Hospital | Principal Investigator |
| Zhaohui Zhu, MD | Peking Union Medical College Hospital | Principal Investigator |
| 33221195 | Background | Gangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19. |
| 34431971 | Background | Kennedy GT, Azari FS, Bernstein E, Marfatia I, Din A, Kucharczuk JC, Low PS, Singhal S. Targeted Intraoperative Molecular Imaging for Localizing Nonpalpable Tumors and Quantifying Resection Margin Distances. JAMA Surg. 2021 Nov 1;156(11):1043-1050. doi: 10.1001/jamasurg.2021.3757. |
| 37019717 | Background | Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |