99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

Not Applicable

Recruiting

• Conditions: Pulmonary Fibrosis
• Interventions: Drug: 99mTc-HFAPI

• Registration Number: NCT05859763
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.

Detailed Description

Idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. Radionuclide labeled FAPI has been developed as a new tracer for tumor and inflammatory lesions imaging. Recent studies have shown that FAPI PET/CT imaging is a promising new imaging method for pulmonary fibrosis. HFAPI is obtained by conjugating 99mTc-chelator moiety (6-hydrazinonicotinamide, HYNIC) with FAP targeting moiety. The aim of this study is to investigate the location and extent of 99mTc labeled FAPI tracer (99mTc-HFAPI) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mTc-HFAPI SPECT/CT in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.

Study Timeline

• Study Start: 2021-12-12
• Status Verified: 2023-05
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• suspected or confirmed pulmonary fibrosis patients;
• signed written consent.

Exclusion Criteria

• pregnancy;
• breastfeeding;
• known allergy against FAPI
• any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with pulmonary fibrosis	99mTc-HFAPI	Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	through study completion, an average of 1.5 years	Qualitative and semi-quantitative analysis (T/N ratio of lesions and adjacent normal tissue, and early and late imaging) of 99mTc-HFAPI SPECT/CT for pulmonary fibrosis

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Dongcheng, China