Hypoxia-Ischemia, Brain Clinical Trial
Official title:
Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain
In today's medical field, there is a growing emphasis on the development of functional and molecular imaging. Therefore, it has significant technical limitations. To address this issue, this project aims to develop a high-speed multimodal photoacoustic/ultrasound functional imaging system that provides both structural and functional information of tissue and organs, thus enhancing the accuracy of early screening and diagnosis of neonatal cranial lesions. This imaging technology is entirely non-invasive and does not involve ionizing radiation or contrast agents. Products using the same technology have already received FDA approval and entered clinical use in the United States. We develop a new generation of multimodal photoacoustic/ultrasound functional imaging equipment to reveal the physiological characteristics and structural details of neonatal cranial lesions, offering advantages and complementary information compared to traditional medical imaging methods.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Day to 7 Days |
Eligibility | Inclusion Criteria: ? All patients were clinically diagnosed as hypoxic-ischemic encephalopathy. ? infants born within 1-7 days (including 7 days); ? The gestational age was 37-42 weeks; ? body weight between 2.5kg and 4kg; ? Color Doppler ultrasound and magnetic resonance imaging were performed in all patients. ? Complete clinical records Exclusion Criteria: ? Children with contraindications to MRI examination; ? Brain tumor, congenital heart disease; ? unclear clinical diagnosis; ? a definite history of intrauterine infection; ? image quality affects the diagnosis of newborns; ? Lack of complete clinical medical records. |
Country | Name | City | State |
---|---|---|---|
China | Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy | The photoacoustic/ultrasound multimodal functional imaging data can be used to analyze the specific physiological characteristics of neonatal brain lesions and evaluate the diagnostic basis. The expected accuracy of this technology in diagnosing specific brain lesions can be evaluated before the end of the study | one year |
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