Surreal illustration of PET scanner with fluoromethylcholine structure

PET Scans Made Easier: Automated Production of [18F]Fluoromethylcholine

Jordan Keane in Health & Wellness December 2025 • 4 min read.

"New tech streamlines the synthesis of a vital imaging agent, improving access to diagnostic tumor imaging and setting new GMP standards for quality assurance."

Positron emission tomography (PET) has become a cornerstone of modern medical imaging, providing unparalleled insights into tumor diagnosis. This technique hinges on radiopharmaceuticals (RPs), specially designed compounds labeled with short-lived, positron-emitting radioisotopes, allowing clinicians to visualize and assess biological processes at the molecular level.

Among these RPs, [18F]fluoromethylcholine ([18F]FMChol) stands out as a popular choice, derived from choline, it excels in diagnosing brain and prostate tumors. The demand for [18F]FMChol in PET imaging underscores the need for efficient and reliable synthesis methods to meet clinical needs and research demands.

Recognizing the critical importance of radiation protection and adherence to Good Manufacturing Practice (GMP) standards, the development of automated synthesis methods for PET RPs has become paramount. Automation not only reduces radiation exposure to personnel but also ensures consistent product quality through precise, step-by-step control of the synthesis process, a key indicator of the quality of the final RP product.

How Does Automation Improve [18F]Fluoromethylcholine Synthesis?

Surreal illustration of PET scanner with fluoromethylcholine structure

The study details the development of an automated technology for synthesizing [18F]fluoromethylcholine, a crucial radiopharmaceutical used in diagnostic positron-emission-tomography tumor imaging. The system leverages a TRACERlab FXFN synthesis module (GE Healthcare) incorporating a combined approach of on-line alkylation and solid-phase extraction. The module was enhanced to operate effectively across varying helium flow rates during critical process steps, increasing the efficiency and adaptability of the synthesis.

Key modifications to the TRACERlab FXFN module were essential in optimizing the [18F]FMChol synthesis. The ability to precisely control helium flow rates allowed for better management of volatile intermediates, particularly during the production of 18F-labeled [18F]FCH2Br. This control is vital for effectively separating and purifying the desired product, preventing unwanted byproducts from interfering with the synthesis.

The optimization of helium flow rates, critical for managing volatile intermediates.
Integration of on-line alkylation and solid-phase extraction techniques.
Enhanced process control to meet stringent GMP standards.

The optimized automated synthesis process resulted in a radiochemical yield of [18F]fluoromethylcholine exceeding 10%, sufficient for producing multiple clinical doses. The quality control parameters of the synthesized [18F]fluoromethylcholine met all requirements set forth by the RF Pharmacopoeia, ensuring its safety and efficacy for clinical applications. This compliance underscores the reliability and suitability of the automated method for routine production of this important radiopharmaceutical.

The Future of Automated Radiopharmaceutical Production

The successful development and implementation of automated [18F]FMChol synthesis represents a significant advancement in radiopharmaceutical production. By streamlining the process and ensuring high levels of quality control, this technology has the potential to improve the availability and accessibility of PET imaging for cancer diagnosis.

The modifications made to the TRACERlab FXFN module, particularly the enhanced control over helium flow rates and the integration of advanced separation techniques, demonstrate a commitment to optimizing radiopharmaceutical synthesis. These advancements pave the way for more efficient and reliable production of other PET tracers, expanding the capabilities of molecular imaging in clinical practice.

As automated synthesis technologies continue to evolve, the future of radiopharmaceutical production looks promising. With increased efficiency, reduced radiation exposure, and improved product quality, automated methods will play an increasingly vital role in advancing medical imaging and improving patient outcomes.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1007/s11094-018-1889-z, Alternate LINK

Title: Automated Synthesis Of [18F]Fluoromethylcholine For Positron-Emission Tomography Imaging

Subject: Drug Discovery

Journal: Pharmaceutical Chemistry Journal

Publisher: Springer Science and Business Media LLC

Authors: O. S. Fedorova, F. P. Vaitekhovich, R. N. Krasikova

Published: 2018-11-01

Everything You Need To Know

What is positron emission tomography (PET) and what role does [18F]fluoromethylcholine play in tumor diagnosis?

Positron emission tomography (PET) relies on radiopharmaceuticals (RPs), which are compounds labeled with short-lived, positron-emitting radioisotopes. These RPs enable clinicians to visualize and assess biological processes at the molecular level, offering unparalleled insights into tumor diagnosis and other medical conditions. [18F]fluoromethylcholine ([18F]FMChol) is specifically used because it is derived from choline and has proven effective in diagnosing brain and prostate tumors.

How does automating the synthesis process of [18F]fluoromethylcholine ([18F]FMChol) improve its production?

Automation significantly improves the synthesis of [18F]fluoromethylcholine ([18F]FMChol) by reducing radiation exposure to personnel and ensuring consistent product quality. This is achieved through precise, step-by-step control of the synthesis process. Specifically, the TRACERlab FXFN synthesis module, enhanced with optimized helium flow rates and combined on-line alkylation and solid-phase extraction techniques, ensures the efficient and reliable production of [18F]FMChol.

What specific modifications were made to the TRACERlab FXFN module to optimize the synthesis of [18F]fluoromethylcholine?

The key modifications included optimizing helium flow rates to better manage volatile intermediates during the production of 18F-labeled [18F]FCH2Br. Precise control over helium flow allows for efficient separation and purification of the desired product, preventing unwanted byproducts from interfering with the synthesis. The integration of on-line alkylation and solid-phase extraction techniques further streamlines the process.

How does the automated synthesis of [18F]fluoromethylcholine ([18F]FMChol) ensure quality control and compliance with regulatory standards?

The automated synthesis of [18F]fluoromethylcholine ([18F]FMChol) ensures high levels of quality control, meeting stringent Good Manufacturing Practice (GMP) standards and RF Pharmacopoeia requirements. This compliance guarantees the safety and efficacy of the radiopharmaceutical for clinical applications, making it suitable for routine production. The high radiochemical yield, exceeding 10%, is sufficient for producing multiple clinical doses.

What are the broader implications of automated [18F]fluoromethylcholine ([18F]FMChol) production for cancer diagnosis and treatment?

The automated production of [18F]fluoromethylcholine ([18F]FMChol) has broader implications for cancer diagnosis. By enhancing the accessibility and availability of PET imaging, it allows for earlier and more accurate diagnoses of tumors, particularly in the brain and prostate. This advancement paves the way for more effective treatment strategies and improved patient outcomes. The standardization of processes could lead to wider adoption and reduced costs, further democratizing access to advanced diagnostic imaging.