Clinical Study of Trap-(FAPI)3 PET Imaging in the Diagnosis of Pulmonary Nodules

Condition(s) studied

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

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)

More Daping Hospital and the Research Institute of Surgery of the Third Military Medical University trials in China

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