FAP-targeted PET/NIR in Lung Malignant Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorPeking University People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET/CT scans
Diagnostic testPET 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: FAP-targeted PET in lung malignant tumors1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)2
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.
Time frame
From preoperative imaging to postoperative pathological assessment (within 4 weeks)Secondary outcomes
1
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.
Time frame
Postoperative specimen analysis (within 2-3 weeks after surgery)2
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.
Time frame
Postoperative specimen analysis (within 2-3 weeks after surgery)Sponsors and contacts
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Source ClinicalTrials.gov