FAP-targeted PET/NIR in Lung Malignant Tumors

NCT07498933 | Recruiting

• 1 other identifier: 2101000672
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer; PET/CT; Neoadjuvant Therapy

Keywords

PET Imaging; NIR Imaging; Neoadjuvant Therapy; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Correlation between fluorescence signal intensity and pathological features

  Postoperative specimen analysis (within 2-3 weeks after surgery)

• Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens

  Postoperative specimen analysis (within 2-3 weeks after surgery)

Study Arms (1)

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.

Diagnostic Test: PET/CT scans

Interventions

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.

FAP-targeted PET in lung malignant tumors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 33538338 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.

  PMID: 37683638 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.

  PMID: 33221195 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.

  PMID: 34431971 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.

  PMID: 37019717 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kezhong Chen, MD

  Peking University People's Hospital

  STUDY DIRECTOR

• Jun Wang, M.M.

  Peking University People's Hospital

  STUDY CHAIR

• Hao Li, MD

  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

Central Study Contacts

Kezhong Chen, MD

CONTACT

+86-010-88325983; mdkzchen@163.com

Qingyun Liu, MD

CONTACT

qingyun_liu919@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thoracic Oncology Institute

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: June 3, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)