Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Phase
Observational
Started
2026-03-01
Last updated
2026-03-04
Condition(s) studied
Lung Nodules
Study summary
The excellent tumor-targeting efficacy of FAP has been confirmed by multiple clinical studies. The results unequivocally establish FAPI as a tumor-targeting ligand with significant potential, demonstrating important application prospects in translational oncology. However, its therapeutic effects remain under investigation. An ideal radiopharmaceutical for cancer treatment should possess outstanding targeting specificity and relatively prolonged tumor retention time. Previous studies have shown that radiolabeled FAPI variants (FAPI-04 and FAPI-46) rapidly and satisfactorily accumulate in tumors, while exhibiting low physiological uptake in normal tissues. However, prior FAP-related tracers demonstrated relatively short retention times in small pulmonary lesions. Our aim is to design a FAPI trimer, Trap-(FAPI)3, to optimize pharmacokinetics and evaluate whether this novel drug offers superior advantages over its monomer analogs in the imaging diagnosis and staging of pulmonary tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\) Patients aged over 18 years with no gender restriction;
* 2\) Patients with radiographic findings of pulmonary nodules;
* 3\) Patients eligible for Trap-(FAPI)3 PET examination;
* 4\) Written informed consent signed by the subject or their legal guardian.
Exclusion Criteria:
* 1\) Patients who have received antitumor therapy prior to PET/CT scanning;
* 2\) Patients with severe diseases that cannot tolerate PET/CT scanning;
* 3\) Alternative subjects with contraindications to PET/CT scanning;
* 4\) Radiation exposure exceeding 50 mSv dose in the past year;
* 5\) Alternative subjects who underwent major surgery within the past 3 months; those who received experimental drugs or devices (with unclear efficacy or safety) within the past 1 month;
* 6\) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.
Primary outcome measure(s)
Diagnostic efficacy of Trap-(FAPI)3 probe for pulmonary nodules — through study completion, an average of 1 year sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,
Histologic Scores for Fibrotic — Completed within one week after surgery Paraffin section specimens were stained by using Masson trichrome for the histologic fibrosis score. Two pathologists graded the histologic slices from the most severe areas for fibrosis by using a semiquantitative scoring system. The fibrosis score was scored between 0 and 3 points as follows: 0: none (No fibrosis), 1: mild (Minimal fibrosis in submucosa or subserosa), 2: moderate (Increased submucosal fibrosis, septa into
muscularis propria and/or septa through muscularis propria, increase in subserosal collage), 3: severe (Significant transmural scar, marked subserosal collagen).
Metabolic parameters — Completed within one week after PET examination Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.
Trial sites (1)
Facility
City
Region
Status
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing
Chongqing Municipality
More Daping Hospital and the Research Institute of Surgery of the Third Military Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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