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

NCT07448441 | Not Yet Recruiting

• 1 other identifier: 2026033
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Nodules

Outcome Measures

Primary Outcomes (3)

• Diagnostic efficacy of Trap-(FAPI)3 probe for pulmonary nodules

  sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

  through study completion, an average of 1 year

• 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).

  Completed within one week after surgery

• Metabolic parameters

  Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.

  Completed within one week after PET examination

Study Arms (1)

patients with pulmonary nodules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects we selected are adults who are not restricted by gender. Fordetails, please refer to the "EligibilityCriteria" colymn.

You may qualify if:

• \) Patients aged over 18 years with no gender restriction;
• \) Patients with radiographic findings of pulmonary nodules;
• \) Patients eligible for Trap-(FAPI)3 PET examination;
• \) Written informed consent signed by the subject or their legal guardian.

You may not qualify if:

• \) Patients who have received antitumor therapy prior to PET/CT scanning;
• \) Patients with severe diseases that cannot tolerate PET/CT scanning;
• \) Alternative subjects with contraindications to PET/CT scanning;
• \) Radiation exposure exceeding 50 mSv dose in the past year;
• \) 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;
• \) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)