99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

Official title:

99mTc-Labeled FAPI SPECT Imaging in Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859763
• Other study ID #: TcHFAPIPF
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: Yu Liu, MD
• Phone: 18511071577
• Email: liuyu[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• 99mTc-HFAPI
Each patient receive a intravenous injection of 99mTc-HFAPI, and undergo SPECT/CT scan within specified time.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Dongcheng

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	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	through study completion, an average of 1.5 years