68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
NCT ID: NCT02511197
Last Updated: 2017-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
30 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-NOTA-PRGD2 injection & PET/CT scan
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.
68Ga-NOTA-PRGD2
68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans
PET/CT
Interventions
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68Ga-NOTA-PRGD2
68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans
PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhaohui Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PUMCHNM10
Identifier Type: -
Identifier Source: org_study_id
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