99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

NCT ID: NCT05859763

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-12
• Study Completion Date: 2024-07-01

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.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with pulmonary fibrosis

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

Group Type: EXPERIMENTAL

99mTc-HFAPI

Intervention Type: DRUG

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

Interventions

99mTc-HFAPI

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking union medical college hospital

Beijing, Dongcheng, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Liu, MD

Role: CONTACT

liuyu@pumch.cn

18511071577

Hongli Jing, MD

Role: CONTACT

Facility Contacts

Yu Liu, MD

Role: primary

liuyu@pumch.cn

18511071577

Other Identifiers

TcHFAPIPF

Identifier Type: -

Identifier Source: org_study_id