Pulmonary Fibrosis, Unspecified Clinical Trial
Official title:
Safety and Diagnostic Performance of 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking Union Medical College Hospital | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking Union Medical College Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual assessment of lung lesions | Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. | 1 year | |
| Primary | 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 | Adverse events collection | Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed. | 5 days | |
| Secondary | Routine blood test | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours | |
| Secondary | Serum albumin | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours | |
| Secondary | Routine urine test | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test. | 24 hours |