Clinical trial NCT02511197: 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
Official title: Safety and Diagnostic Performance of 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pulmonary Fibrosis, Unspecified
Keywords: PET
lung injury
integrin receptor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 30
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: 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.

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 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.

Primary outcomes:
measure: Visual assessment of lung lesions
timeFrame: 1 year
measure: Semiquantitative assessment of lung lesions
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 5 days
measure: Routine blood test
timeFrame: 24 hours
measure: Serum albumin
timeFrame: 24 hours
measure: Routine urine test
timeFrame: 24 hours
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: