Speaker
Description
Background: Alzheimer’s disease (AD) is the leading cause of dementia worldwide and poses an escalating public health burden, particularly in aging populations. Accurate early diagnosis is essential for optimal patient management and the implementation of emerging disease-modifying therapies. Positron emission tomography (PET) imaging with 18F-Florbetapir enables noninvasive in vivo detection of β-amyloid plaques, a defining neuropathological feature of AD, and has demonstrated superior diagnostic accuracy compared with clinical assessment alone. Nevertheless, access to amyloid PET imaging remains limited in many countries due to the high cost and restricted availability of radiopharmaceuticals.
Methods / Development: The Siriraj Cyclotron Centre has developed the capability for local production of 18F-Florbetapir using a modified in-house synthesis protocol derived from previously published methods and related Alzheimer’s disease research conducted by Siriraj Nuclear Medicine team and collaborators. Production is performed using an automated synthesis system involving nucleophilic substitution of 18F-fluoride, followed by purification and sterile formulation suitable for intravenous administration. Comprehensive quality control testing is conducted in accordance with established radiopharmaceutical standards to ensure product identity, purity, safety, and suitability for clinical use.
Future Implementation: The patent protection associated with the licensed commercial production of 18F-Florbetapir is anticipated to expire in 2027. In preparation for this development, the Division of Nuclear Medicine, Department of Radiology, Faculty of Medicine Siriraj Hospital, plans to implement a clinical amyloid PET imaging service utilizing locally produced 18F-Florbetapir. This initiative aims to provide a cost-effective diagnostic modality while maintaining high standards of image quality, production reliability, and patient safety. Establishing domestic manufacturing capability is expected to reduce dependence on imported radiopharmaceuticals, enhance accessibility for patients in Thailand, and support clinical and translational research in neurodegenerative disorders.
Conclusion: The establishment of local 18F-Florbetapir production at Siriraj Hospital represents a significant advancement toward expanding access to advanced molecular imaging for Alzheimer’s disease in Thailand. Following the anticipated expiration of patent restrictions, this program has the potential to deliver affordable, high-quality amyloid PET services while strengthening national capacity in both clinical care and research on neurodegenerative diseases. Upon successful implementation, this program has the potential to serve as a model for other centers in Thailand and throughout Southeast Asia to establish local production of various radiopharmaceuticals, thereby enhancing regional capacity and expanding access to advanced medical services.
Reference:
1. Siriprapa T, Thientunyakit T, Gelovani J. Amyloid PET Radiopharmaceuticals and Imaging for Clinical and Research Applications in Thailand. Siriraj Med J. 2023 Sep. 1;75(9):688-9.
2. Tanyaluck Thientunyakit, Weerasak Muangpaisan, Orasa Chawalparit, Chakmeedaj Sethanandha, Siriwan Piyapittayanan, Tossaporn Siriprapa and Kuntarat Arunrungvichian, Brain amyloid PET scan in Alzheimer’s disease, mild cognitive impairment and normal aging: The first prospective longitudinal study in Thailand. Journal of Nuclear Medicine May 2021, 62 (supplement 1) 1061.
3. Tossaporn Siriprapa, Tanyaluck Thientunyakit, Production and Quality Control of [F-18 ]Florbetapir PET Tracers for Diagnosing Cardiac Amyloidosis by Two CFN Multi-Purpose Synthesizers at Siriraj Hospital. International Conference on Integrated Medical Imaging in Cardiovascular Diseases.
| Track | Deployment of Nuclear Medicine in LMICs: Enabling Technologies |
|---|---|
| Presentation type | Poster |