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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Stanford University

Criteria

Inclusion Criteria:

Patients with idiopathic pulmonary fibrosis

• Males and females, ≥18 years old

• Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of IPF.

• The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing IPF. They rely on a combination of clinical, radiological, operative and histological findings, in addition to results of other laboratory tests.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential

• Renal function: serum creatinine >3.0 mg/dL (270 μM/L)

• Liver function: any hepatic enzyme level more than 5 times upper limit of normal.

• Known severe allergy or hypersensitivity to IV radiographic contrast.

• Patients not able to enter the bore of the PET/CT scanner.

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.