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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGVisual and semiquantitative assessment of lesions
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.
Time frame: 1 year
Blood pressure
Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Pulse
Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Respiration frequency
Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Temperature
Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Routine blood test
Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Routine urine test
Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum albumin
Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum creatinine
Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.
Time frame: 5 days
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