About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
The subjects we selected are adults who are not restricted by gender. Fordetails, please refer to the "EligibilityCriteria" colymn.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic efficacy of Trap-(FAPI)3 probe for pulmonary nodules
sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,
Histologic Scores for Fibrotic
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
Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.
Sponsors and contacts
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