Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain

NCT06139250 | Unknown

• 1 other identifier: 2023-brain
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia-Ischemia, Brain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

hypoxic-ischemic encephalopathy group

Photoacoustic/ultrasound imaging will be used for neonates with hypoxic ischemic encephalopathy

control group

Photoacoustic/ultrasound imaging will be used for neonates without brain disease

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

1. Neonates with hypoxic ischemia encephalopathy group ① All patients were clinically diagnosed as HIE. ② infants born within 1-7 days (including 7 days); ③ The gestational age was 37-42 weeks; ④ body weight between 2.5kg and 4kg; ⑤ Color Doppler ultrasound and magnetic resonance imaging were performed in all patients. ⑥ Complete clinical records 2. Control group：① There was no neonatal encephalopathy. ② born within 1-7 days (including 7 days); ③ The gestational age was 37-42 weeks; ④ Body weight between 2.5kg and 4kg

You may qualify if:

• ① All patients were clinically diagnosed as hypoxic-ischemic encephalopathy. ② infants born within 1-7 days (including 7 days); ③ The gestational age was 37-42 weeks; ④ body weight between 2.5kg and 4kg; ⑤ Color Doppler ultrasound and magnetic resonance imaging were performed in all patients. ⑥ Complete clinical records

You may not qualify if:

• ① Children with contraindications to MRI examination; ② Brain tumor, congenital heart disease; ③ unclear clinical diagnosis; ④ a definite history of intrauterine infection; ⑤ image quality affects the diagnosis of newborns; ⑥ Lack of complete clinical medical records.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pintong Huang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yajing Liu

CONTACT

18805064970; liuyajing@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

CN (1)