68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
कीवर्ड
सार
विवरण
For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF). A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
खजूर
| अंतिम सत्यापित: | 05/31/2015 |
| पहले प्रस्तुत किया गया: | 06/25/2015 |
| अनुमानित नामांकन प्रस्तुत किया गया: | 06/25/2015 |
| पहले पोस्ट किया गया: | 06/29/2015 |
| अंतिम अद्यतन प्रस्तुत किया: | 04/04/2017 |
| अंतिम अद्यतन पोस्ट: | 04/06/2017 |
| वास्तविक अध्ययन प्रारंभ दिनांक: | 12/31/2014 |
| अनुमानित प्राथमिक समापन तिथि: | 11/30/2017 |
| अनुमानित अध्ययन पूर्णता तिथि: | 11/30/2017 |
स्थिति या रोग
हस्तक्षेप / उपचार
Drug: 68Ga-BMV101 injection and PET/CT scan
चरण
शाखा समूह
| बांह | हस्तक्षेप / उपचार |
|---|---|
| Experimental: 68Ga-BMV101 injection and PET/CT scan The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that. | Drug: 68Ga-BMV101 injection and PET/CT scan 68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans. |
पात्रता मापदंड
| युग अध्ययन के लिए पात्र | 18 Years सेवा 18 Years |
| सेक्स अध्ययन के लिए पात्र | All |
| स्वस्थ स्वयंसेवकों को स्वीकार करता है | हाँ |
| मानदंड | Inclusion Criteria: Patients with idiopathic pulmonary fibrosis - Males and females, ≥18 years old - Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of IPF. - The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing IPF. 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. |
परिणाम
प्राथमिक परिणाम उपाय
1. Visual and semiquantitative assessment of lesions [1 year]
माध्यमिक परिणाम उपाय
1. Blood pressure [24 hours]
2. Pulse [24 hours]
3. Respiration frequency [24 hours]
4. Temperature [24 hours]
5. Routine blood test [24 hours]
6. Routine urine test [24 hours]
7. Serum alanine aminotransferase [24 hours]
8. Serum albumin [24 hours]
9. Serum creatinine [24 hours]
10. Adverse events collection [5 days]
