68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

Status Recruiting

Clinical Trial Summary

Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. Because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents 68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.

Clinical Trial Description

For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF). A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients. ;

Study Design

Related Conditions & MeSH terms

Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis

Clinical Trial Details

NCT number	NCT02485886
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Zhaohui Zhu, MD
Phone	+8613611093752
Email	13611093752@163.com
Status	Recruiting
Phase	Early Phase 1
Start date	January 2015
Completion date	December 2017

View Details

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