Clinical trial NCT02485886: 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Official title: Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: PET
interstitial pulmonary fibrosis (IPF)
cysteine cathepsins
macrophage
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2015-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Visual and semiquantitative assessment of lesions
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 hours
measure: Pulse
timeFrame: 24 hours
measure: Respiration frequency
timeFrame: 24 hours
measure: Temperature
timeFrame: 24 hours
measure: Routine blood test
timeFrame: 24 hours
measure: Routine urine test
timeFrame: 24 hours
measure: Serum alanine aminotransferase
timeFrame: 24 hours
measure: Serum albumin
timeFrame: 24 hours
measure: Serum creatinine
timeFrame: 24 hours
measure: Adverse events collection
timeFrame: 5 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: