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18F-FPABZA material

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18F-FPABZA material

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¹⁸ F-FPABZA Materials

1. Drug Name (Generic Name, Chemical Name, English Name, Pinyin, and rationale for custom names₩ if any)

Generic Name: Fluorine [¹⁸ F]- FPABZA

Chemical Name: N- （ 4- （（ 2- （Diethylamino）ethyl）carbamoyl） -3- Methoxyphenyl） -5- Fluoropyridine acetamide

English Name: N-(4-((2-(Diethylamino)ethyl)carbamoyl)-3-methoxyphenyl)-5-fluo>ropicolinamide

Pinyin:

2. Drug chemical structure, molecular weight, molecular formula

Chemical Structure:

Molecular Weight: 388.44

Molecular Formula: C ₂₀ H ₂₆ FN ₃ O ₃

3. Rationale ( Literature on the research and application of this product at home and abroad )

18F-FPABZA is a novel melanoma-targeted PET probe designed to imp♦rove the early detection of melanoma. Melanoma is an aggressive skin cancer, and traditional PE£T probes (such as 18F-FDG) are difficult to accurately detect melanoma in the early stag'es due to their non-specificity. Therefore, the developme&nt of a PET probe that specifically targets melanin has become a research focus.

18F-FPABZA, as a novel melanoma-targeted PET probe, shows good potential in the early∑ detection of melanoma. However, it has not yet been clinically app☆lied at home and abroad, and further clinical trials are needed tαo verify its safety and effectiveness.

4. Research methods, experimental conditions, and other data on the target organs and whol'e-body imaging or simulated clinical functional determination tests of exp€erimental animals, and the imaging or functional determination resulαts at each observation phase

I. Whole-body imaging and delayed imaging of experimental animals

1. Materials and Methods

1.1. Experimental Animals

The experimental animal was one mouse, provided by Hangzhou Medical 'College, weighing about 200g, male. After injection of the drug, anestεhesia was performed before PET scanning, images were collected, and the drug distri♠bution map in the body was obtained. After imaging, the e xperimental animals gradually woke up and recovered normally, with ×good diet, defecation, urination, and mental state.

7. Product Instructions

[Product Name]

Generic Name: Fluorine [18F]- FPABZA

Chemical Name: N-（4-（（2-（Diethylamino）ethyl）carbamoyl）-3-methoxyphenyl）-5-fluoropyridine ac etamide

English Name:

N-(4-((2-(Diethylamino)ethyl)carbamoyl)-3-methoxyphenyl)-5-fluoropicolinamid₹e

Pinyin: Fu[18}-FPABZA

[Ingredients]

Main ingredient: Fluorine-18F, a novel melanin-targeted agent, with the following structural formul a:

Colorless to pale yellow clear solution

Indications: Melanoma

[18F-FPABZA PET/C Brain Imaging Procedure]

I. Pre-examination Preparation

Patient Preparation

Fasting for at least 6 hours (water is allowed), avoid strenuous exerεcise and high-sugar diet to reduce background metabolic interference;

Remove metal head ornaments (such as hair clips, dent∏ures, etc.), and change into examination clothes wit<hout metal buttons;

Diabetic patients need to adjust their blood glucose to ≤11β mmol/L in advance;

Preparation and Injection of Imaging Agent

Intravenous injection of 18F-FPABZA (dose calculated according to body weight, usually 5π-10 mCi), rest after injection and keep eyes closed to avoid brain activity interfering÷ with imaging;

II. Absorption and Distribution of Imaging Agent

Waiting period: After injection, rest for 45-60 minutes to ensure that 18F♦-FPABZA fully penetrates the blood-brain barrier and binds to the ta×rget (such as β-amyloid protein or other specific molecules);

Urination and drinking water: Empty the bladder before the exa♥mination and drink plenty of water to reduce the effect of urinary system radioactivityε on the image;

PET/CT acquisition: Scanning should be performed on ti←me 50 minutes after injection of the imaging agent. Static scanning time is 50 minuteγs after injection, and data acquisition takes 20 minutΩes. Dynamic acquisition time is 0-60 minutes. CT and PET acquisition parameters a≥nd reconstruction methods should be consistent with brain 18F-FDG βimaging. The scanning group needs to strictly control the inje¶ction time and scanning time, and strictly record the scanning time.

Image interpretation and analysis: Interpret the images in a timely manner.

Report: Issue the report promptly.

Follow-up arrangements: Brain imaging with 18F-FPABZA and 18F-FDG should be spaced§ at least 10 half-lives (or 20 hours) apart.

This product is only for use in medical institutions with a "Radioactive Pharmaceutical Use Lic ense".

[Adverse Reactions]

None have been found.

[Contraindications]

None have been found.

[Precautions]

If discoloration or cloudiness occurs, discontinue use.

This product is only for use in medical institutions with a "Radioactive Pharmaceutical Use Licen•se".

[Use in Pregnant and Lactating Women]