Idiopathic Pulmonary Fibrosis
Conditions
Keywords
PET, interstitial pulmonary fibrosis (IPF), cysteine cathepsins, macrophage
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.
Interventions
DRUG68Ga-BMV101
68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
Sponsors
Stanford University
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual and semiquantitative assessment of lesions | 1 year | Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lungs will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Routine blood test | 24 hours | Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment. |
| Routine urine test | 24 hours | Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment. |
| Blood pressure | 24 hours | Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment. |
| Pulse | 24 hours | Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment. |
| Temperature | 24 hours | Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment. |
| Serum alanine aminotransferase | 24 hours | Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment. |
| Serum albumin | 24 hours | Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment. |
| Serum creatinine | 24 hours | Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment. |
| Adverse events collection | 5 days | Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed. |
| Respiration frequency | 24 hours | Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment. |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD
Outcome results
None listed