Hypoxia-Ischemia, BrainNCT06139250
Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain
An observational study of Hypoxia-Ischemia, Brain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Hypoxia-Ischemia, Brain
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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.
Read the detailed description
Medical imaging plays a huge role in clinical diagnosis. At present, the commonly used imaging methods for neonatal brain imaging include ultrasound imaging, magnetic resonance imaging, and CT. Due to the imaging scale, speed, and radiation limitation, large imaging devices such as CT and magnetic resonance imaging usually have limitations in the early screening and diagnosis of neonatal brain lesions. With the advantages of flexibility and convenience, ultrasound has become a common imaging method for neonatal brain organs. However, conventional ultrasound imaging usually only provides structure-related information, and it is difficult to reveal the physiological characteristics of the lesions. Therefore, this project aims to develop a high-speed multi-modal photoacoustic/ultrasound functional imaging system to provide structural and functional information of tissues and organs, thereby improving the accuracy of early screening and diagnosis of neonatal brain lesions. The imaging technique is completely noninvasive and does not use any ionizing radiation or contrast media. A product that uses the same technology as this imaging device has been approved by the FDA and entered the clinic in the United States.
The imaging device consists of two imaging modalities, photoacoustic imaging and ultrasound imaging. Photoacoustic imaging (PAI) can be used to image the optical absorption characteristics of human tissues by safely irradiating the human body with near-infrared light (complying with international safety standards) to produce a short time temperature rise (less than 0.1 degrees Celsius), resulting in a weak ultrasound signal. The ultrasonic imaging principle of the device is the same as that of clinical B-ultrasound, which uses ultrasound to safely irradiate the body (obeying international safety standards) and obtain reflected signals. This project is supported by the Young Scientist Project of Diagnosis and Treatment Equipment of the Key Research and Development Program of the Ministry of Science and Technology, jointly applied by the research group of Teacher Lin Li from Zhejiang University and the research group of Huang Pin from the Second Affiliated Hospital of Zhejiang University School of Medicine. This project aims to develop a new generation of multimodal photoacoustic/ultrasound functional imaging equipment to reveal the physiological characteristics and structural details of neonatal brain lesions. And traditional medical imaging methods form advantages and information complementary.
- Conditions
- Hypoxia-Ischemia, Brain
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pintong Huang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139250
- Sponsor's protocol ID
- 2023-brain
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain
- ClinicalTrials.gov ID
- NCT06139250
- Acronym / sponsor ID
- 2023-brain
- Conditions
- Hypoxia-Ischemia, Brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Medical imaging plays a huge role in clinical diagnosis. At present, the commonly used imaging methods for neonatal brain imaging include ultrasound imaging, magnetic resonance imaging, and CT. Due to the imaging scale, speed, and radiation limitation, large imaging devices such as CT and magnetic resonance imaging usually have limitations in the early screening and diagnosis of neonatal brain lesions. With the advantages of flexibility and convenience, ultrasound has become a common imaging method for neonatal brain organs. However, conventional ultrasound imaging usually only provides structure-related information, and it is difficult to reveal the physiological characteristics of the lesions. Therefore, this project aims to develop a high-speed multi-modal photoacoustic/ultrasound functional imaging system to provide structural and functional information of tissues and organs, thereby improving the accuracy of early screening and diagnosis of neonatal brain lesions. The imaging technique is completely noninvasive and does not use any ionizing radiation or contrast media. A product that uses the same technology as this imaging device has been approved by the FDA and entered the clinic in the United States.
The imaging device consists of two imaging modalities, photoacoustic imaging and ultrasound imaging. Photoacoustic imaging (PAI) can be used to image the optical absorption characteristics of human tissues by safely irradiating the human body with near-infrared light (complying with international safety standards) to produce a short time temperature rise (less than 0.1 degrees Celsius), resulting in a weak ultrasound signal. The ultrasonic imaging principle of the device is the same as that of clinical B-ultrasound, which uses ultrasound to safely irradiate the body (obeying international safety standards) and obtain reflected signals. This project is supported by the Young Scientist Project of Diagnosis and Treatment Equipment of the Key Research and Development Program of the Ministry of Science and Technology, jointly applied by the research group of Teacher Lin Li from Zhejiang University and the research group of Huang Pin from the Second Affiliated Hospital of Zhejiang University School of Medicine. This project aims to develop a new generation of multimodal photoacoustic/ultrasound functional imaging equipment to reveal the physiological characteristics and structural details of neonatal brain lesions. And traditional medical imaging methods form advantages and information complementary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy
Time frame: one year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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Neuro-MoD: Neuroplasticity With Motor Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pintong Huang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia-Ischemia, Brain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yajing Liu (18805064970, liuyajing@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.