99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

99mTc-Labeled FAPI SPECT Imaging in Pulmonary Fibrosis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05859763

Enrollment

150

Registered

2023-05-16

Start date

2021-12-12

Completion date

2024-07-01

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

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.

Interventions

DRUG99mTc-HFAPI

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYu Liu, MD

liuyu@pumch.cn18511071577

Backup ContactHongli Jing, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026