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Clinical Trial NCT07498933 for Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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FAP-targeted PET/NIR in Lung Malignant Tumors 200 Immunotherapy Combination Therapy

Recruiting
Clinical Trial NCT07498933 is an observational study for Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy that is recruiting. It started on 3 June 2025 with plans to enroll 200 participants. Led by Peking University People's Hospital, it is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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, ...Show More
Detailed 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 strom...Show More
Official Title

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

Conditions
Non-Small Cell Lung CancerPET/CTNeoadjuvant Therapy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2101000672
NCT ID Number
NCT07498933
Start Date (Actual)
2025-06-03
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
200
Study Type
Observational
Status
Recruiting
Keywords
PET Imaging
NIR Imaging
Neoadjuvant Therapy
Non-Small Cell Lung Cancer
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
PET/CT scans
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 c...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 1. Age between 18 and 70 years old; 2. Have complete clinical and imaging data; 3. Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer; 4. Able to retain sufficient tumor tissue for testing and research; 5. Sign informed consent.

  • 1. Previously combined with other malignant tumors or received other anti-tumor treatments; 2. Failure to collect sufficient tumor tissue for testing and research; 3. The duration of neoadjuvant therapy is less than 3 cycles; 4. The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing; 5. Lack of clinical and imaging data; 6. There are situations where other researchers consider it inappropriate to participate in this study
Peking University People's Hospital logoPeking University People's Hospital
Study Responsible Party
Chen KeZhong, Principal Investigator, Director of Thoracic Oncology Institute, Peking University People's Hospital
Study Central Contact
Contact: Kezhong Chen, MD, +86-010-88325983, [email protected]
Contact: Qingyun Liu, MD, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Peking University People's Hospital, Beijing, Beijing Municipality, China
Kezhong Chen, MD, Contact, +86-010-88325983, [email protected]
Recruiting