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18F-AV45 material

Keywords: synthetic equipment disposable consumables

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18F-AV45 material

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18F-AV45 material

1. Drug name (generic name, chemical name, English name, Pinyin, if there is a customized name, the basis of naming should be explained)

common name:

Fluor [18F]- β -amyloid injection

chemical name:

(E)-4-(2-(6-(2-(2-(2-(2-18F-fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylaniline

English name:

Fluorine18(18F)-β-amyloidprotein,Aβ

pin yin:

Fu[18F] β-dingfenyangdanbai Zhusheye

2. Chemical structure, molecular weight and molecular formula of the drug

chemical constitution:

Molecular weight: 359.19

Molecular formula: C₂₀H₂₅¹⁸FN₂O₃

3. Basis of the topic (literature on the development and application of this product at home and abroad)

internal

Research and Development: Domestic research teams are conducting relevant studies in the field of radiopharmaceuticals. For example, the team led by Academician Liu Boli at Beijing Normal University has developed a new brain plaque imaging agent that holds promise for becoming a new intellectual property in China. They found that the 18F-labeled benzoxazole derivative (18F) ZB-35a exhibits properties similar to those of 18F-AV45 both in vivo and in vitro in mice, and preclinical studies were underway at the time.

In terms of application: Multiple hospitals have already used 18F-AV45 for clinical diagnosis. For example, the PET Center at Huashan Hospital affiliated with Fudan University has launched early dementia diagnosis and differential diagnosis services, including 18F-AV45, at its East Campus. The Department of Nuclear Medicine (PET Center) at Xiangya Hospital of Central South University has also applied 18F-AV45 for Alzheimer's disease diagnosis and pioneered the use of 18F-SDM8 neuroimaging in China, achieving international leading standards. Additionally, the team led by Physicist Han Wei from the Department of Nuclear Medicine at Harbin Medical University First Hospital successfully synthesized 18F-AV45 amyloid imaging agent. This advanced medical technology provides precise examination results to clinicians, helping patients develop more optimal treatment plans.

external

Research and Development: Early studies involved in vitro binding assays and autoradiography to investigate the binding of 18F-AV-45 in postmortem AD brain tissue, as well as its biological distribution in mouse and monkey brains. At that time, research indicated that 18F-AV-45 has high binding affinity and specificity for Aβ plaques. During Phase III clinical trials, it was considered a promising PET radiotracer for detecting Aβ plaques in living human brains.

Application: 18F-AV45 is mainly used in the field of Alzheimer's disease diagnosis and research abroad. PET imaging is used to detect β-amyloid deposition in the brain, which helps doctors to diagnose, assess and study Alzheimer's disease at an early stage.

4. Instructions for drugs

[Drug Name]

common name:

Fluorine [18F]- β-amyloid injection

chemical name:

(E)-4-(2-(6-(2-(2-(2-(2-18F-fluoroethoxy)ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylaniline

pin yin:

Fu[18F] β-dingfenyangdanbai Zhusheye

[element]

The main component and its chemical name of this product are: β-amyloid protein with the structural formula:

[shape and properties]

This product is a colorless clear or slightly yellow clear solution.

[indication]

The 18F-AV45 is used for brain diseases: amyloid imaging, for AD, etc.

[18F-AV45 PET/CT brain imaging process]

Patient Appointment: The clinical doctor must communicate and make an appointment with the doctors at this center at least one day in advance. The clinical doctor or the doctor scheduled by this center should inform the patient that they can eat normally on the day of the examination, but if possible, fasting for 2 hours is required. Stop using AD drugs and any medications affecting the brain 24 hours before the AV45 scan. Patients need to report to this center one hour before the scheduled appointment time.

History collection: brief medical history, clinical diagnosis, and informed consent signed by the subjects.

Preparation before examination: inform the patient to drink water and go to the toilet, and do not drink water or go to the toilet again from after injection of imaging agent to before examination.

Before injection: the drug group confirms the measurement time and dose of each injection, and reports to the nursing group. The nursing group confirms the injection time and returns the residue to the drug group, and the drug group records the residual dose and time.

Injection 18F-AV45: only one patient can be injected at a time. The injection dose is 10 mCi (±10%). The nursing team should strictly record the injection time.

Rest for the patient: The subject should be asked to remain quiet, silent and conscious before the examination. During this time, family members or caregivers may accompany them, but please do not talk or use electronic devices.

PET/CT acquisition: The scan must be performed exactly 50 minutes after the injection of the contrast agent. The static scan duration is 50 minutes post-injection, with a collection time of 20 minutes. The dynamic acquisition time ranges from 0 to 70 minutes. The parameters and reconstruction methods for CT and PET acquisition must be consistent with those used for brain 18F-FDG imaging. Strict control over the injection and scan times is required, and the scan times must be meticulously recorded.

Image interpretation and analysis: timely interpretation of images.

Report: Report in time.

Follow-up: 18F-AV45 and 18F-FDG brain imaging should be performed at least 10 half-lives (or 20 hours) apart.

This product is only for use in medical units with a radioactive Drug Use License.

[untoward effect]

Not yet found.

[taboo]

Not yet found.

[matters need attention]

If the product changes color or becomes cloudy, stop using it.

This product is only for use in medical units with a radioactive Drug Use License.

[Pregnant and lactating women]