68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Diagnostic Performance of 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis

Conditions
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Pulmonary Fibrosis, Unspecified

Intervention / Treatment
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* Drug: 68Ga-NOTA-PRGD2
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-PRGD2 injection & PET/CT scan<br>The patients were intravenously injected with 68Ga-NOTA-PRGD2 in one dose in nearly 111 MBq and then underwent PET/CT scan 0.5 h later. | Drug: 68Ga-NOTA-PRGD2<br>* 68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans<br>* Other names: 68Ga-NOTA conjugated with dimer PRGD2;Device: PET/CT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of lung lesions | Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. | 1 year | 
| Semiquantitative assessment of lung lesions | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed. | 5 days | 
| Routine blood test | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours | 
| Serum albumin | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours | 
| Routine urine test | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, lung injury, integrin receptor