Pulmonary Fibrosis, Unspecified
Conditions
Keywords
PET, lung injury, integrin receptor
Brief summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq 68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with LI/PF. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed description
The αvβ3-integrin is a transmembrane heterodimeric receptor that mediates cell-cell and cell-extracellular matrix adhesion. The αvβ3-integrin plays a pivotal role in promoting and sustaining angiogenesis and fibrosis. Cyclic arginine-glycine-aspartic acid (RGD) peptide is the key integrin recognition motif that can strongly bind to the αvβ3-integrin, which makes the RGD-based peptides hold a promise for imaging and treatment of diseases characterised with angiogenesis and fibrosis including LI and PF. Animal study in bleomycin induced lung fibrosis showed good uptake ratio of 68Ga-NOTA-PRGD2 in lung vs background. For interests in clinical translation of 68Ga-NOTA-PRGD2, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-NOTA-PRGD2 in patients with LI or PF.
Interventions
DRUG68Ga-NOTA-PRGD2
68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans
DEVICEPET/CT
Sponsors
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 LI/PF. * The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing LI/PF. 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 assessment of lung lesions | 1 year | Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. |
| Semiquantitative assessment of lung lesions | 1 year | 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 |
|---|---|---|
| Adverse events collection | 5 days | Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed. |
| Routine blood test | 24 hours | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test. |
| Serum albumin | 24 hours | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test. |
| Routine urine test | 24 hours | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test. |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD
Outcome results
None listed