18F-FPCIT (PDvue®) is a radiopharmaceutical used in positron emission tomography (PET) imaging to visualize dopamine transporters in the brain. It is commonly used in the diagnosis of Parkinson’s disease and other movement disorders. By binding to dopamine transporters, 18F-FPCIT can help clinicians assess the integrity of the dopaminergic system in the brain, aiding in the early detection and monitoring of neurodegenerative diseases. Please note that while I can provide general information, it is important to consult with a healthcare professional for specific medical advice or details about this radiopharmaceutical.
Description
18F-FPCIT (18F-FP-CIT, 18F-N-3-fluoropropyl-2-beta-carboxymethoxy-3-β-(4-iodophenyl)nortropane) is the fluorinated equivalent of 123I-Ioflupane (DaTscan). It was developed in the early 2000’s by the South Korean company FutureChem, ASAN Medical Center (AMC) and Duchembio Co. Ltd, and got a marketing authorization for South Korea in May 2008. The tracer was licensed to Cyclotek in June 2017.
Clinical applications
18F-FPCIT is a useful tool in clinical practice to support the diagnosis of Parkinson’s disease and to differentiate between other pathological conditions. Moreover, 18F-FPCIT PET could significantly impact treatment selection and follow-up of these patients. However, it is not yet available (except in South Korea) while its 123I-analogue Ioflupane has been marketed for several years.
18F-FPCIT has the advantage of being a PET imaging agent, which permits absolute quantification of striatal uptake. The shorter half-life and the absence of interaction with the thyroid gives supplementary advantages in terms of dosimetry to the patient compared to the 123I-labeled analogue. The average dose to the patient is 5 mCi.
Availability
18F-FPCIT is available in Korea from one single source (the Seoul site of FutureChem) having a marketing authorization in this country and was brought on this market in September 2009. A few centers outside of Korea have access to the precursor and the manufacturing technology but they use this tracer only for research purposes.
Competition
Presently, there is only one single center in Seoul officially proposing this tracer for imaging. The 123I-Ioflupane (DaTscan) is the real competitor but is not more easily available as it is strongly linked to 123I sources. As DaTscan is available in the US and EU, and as this market is quite small despite the high number of Parkinson’s patients, there is no strong interest for these countries to take over the PET agent.
The close collaboration between Piramal Imaging (formerly part of Bayer-Schering) and FutureChem implies that Piramal Imaging does have access to this tracer and could be the first company interested in collaboration for the extension of the marketing authorization beyond South Korea.
Comments
The sales of DaTscan have no links with the number of Parkinson’s patients in the country where this tracer is available. The limited interest in this tracer is linked both to its high price (itself linked to the cost of manufacturing of a 123I labeled compound) and to the limited advantage of confirming the diagnostic while therapies are not yet available. Introducing another tracer for the same indication on the same market would probably not increase the use of the modality even if the technology is different (PET replacing SPECT)
and the quality of images probably better as well. When such a tracer can be directly linked to a prognosis, to patient stratification or to an efficient therapy, only then there will be an increasing interest for physicians. However, when this opportunity will be in place, it will be too late to start real development of a new tracer.