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Fluorocholine (18F), also known as fluorocholine F-18, is a radioactive diagnostic tracer used in positron emission tomography (PET) imaging. It is a chemically synthesised substance (substance origin: Chemical) and is classified under the Anatomical Therapeutic Chemical (ATC) code V09IX07, a category for diagnostic radiopharmaceuticals used in tumour detection.[1]
The substance is already authorised as a medicine in Italy, where it is supplied by Curium Italy S.r.l. under the product name Fluorocolina (18F) Curium Italy 225 MBq/mL soluzione iniettabile.[2] In the two trials described on this page, fluorocholine (18F) appears once as the test substance and once as a comparator — meaning it is being used both as the tracer under investigation and as a reference standard against which another tracer is compared.[1][2]
Fluorocholine (18F) is taken up by cells that are actively dividing. Tumour cells often show increased choline uptake because they need choline to build cell membranes. When the tracer is injected, it accumulates in areas of high cell proliferation, and the attached radioactive fluorine-18 emits positrons that the PET scanner detects. This produces images showing where abnormal uptake is occurring, helping doctors locate and stage tumours.[3]
In one of the trials, fluorocholine (18F) PET/CT is used as the reference scan against which a newer tracer, 64CuCl2, is compared for detecting metastatic lesions in prostate cancer — specifically focal uptake in bone, lymph nodes, or visceral sites.[2]
Fluorocholine (18F) is supplied as a solution for injection and is given by intravenous administration (injection into a vein). In the prostate cancer trial, the fluorocholine (18F) dose is 400 MBq (megabecquerels), a unit of radioactivity.[2] In the multiplexed PET imaging trial, the dose is 5.4 MBq per kilogram of body weight.[1] After injection, the patient undergoes a PET scan, often combined with CT, to produce the diagnostic images.
Two authorised phase 3 trials involving fluorocholine (18F) are registered in the EU Clinical Trials Information System. Both are interventional diagnostic performance studies, meaning they compare how well different imaging approaches detect tumours.
The larger trial (2025-520861-29-00) is enrolling 285 participants with prostate cancer at risk of developing metastatic lesions. It compares fluorocholine (18F) PET/CT with 64CuCl2 PET/CT, measuring sensitivity and specificity on a patient basis — how often each scan correctly identifies people with metastases and correctly identifies those without.[2]
The smaller trial (2024-519505-35-00) is a basket diagnostic performance study in 28 participants with hepatocellular carcinoma or gastro-entero-pancreatic tumours. It tests a multiplexed PET approach in which two radiopharmaceuticals — fluorocholine (18F) and either gallium (68Ga) edotreotide or fludeoxyglucose (18F) — are injected in a staggered way through a single route. The trial measures safety, technical feasibility of image reconstruction, and diagnostic efficacy compared with single-tracer PET scans.[1]
Both trials measure the number, location, and quantitative information of positive lesions detected by each imaging approach. In the multiplexed imaging trial, two independent experts blinded to the other technique evaluate each scan.[1]
The multiplexed PET imaging trial monitors safety after radiopharmaceutical administration and for 30 minutes after the end of image acquisition, collecting any adverse reactions during that period.[1] The published UK case series on fluorocholine (18F) PET/CT in primary hyperparathyroidism does not report specific side effects in the abstract available.[3] As with all radiopharmaceuticals, the radiation dose is kept as low as possible for diagnostic purposes.
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