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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Early Phase 1

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: 68Ga-BMV101

Study type

Interventional

Funder types

Other

Identifiers

NCT02485886

PUMCHNM09

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.