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

Starting soon

Conditions studied: Lung Nodules

In brief

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.

Key facts

Study ID

NCT07448441

Run by

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

People needed

50

Starts

2026-03-01

Expected to finish

2027-12-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing, Chongqing Municipality, China

Full record on ClinicalTrials.gov

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