99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Pulmonary Fibrosis

Treatments: Drug: 99mTc-HFAPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05859763

TcHFAPIPF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Patients diagnosed with pulmonary fibrosis

Experimental group

Description:

Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.

Treatment:

Drug: 99mTc-HFAPI