{"entity":{"id":"f-18-fdopa","kind":"drug","name":"Fluorodopa F-18","aka":["18F-FDOPA","6-[18F]fluoro-L-DOPA","Fluorodopa F 18 Injection"],"tldr":"A tracer originally built to look at brain dopamine cells in suspected Parkinson's disease. Because certain hormone-producing tumours use the same chemical machinery, doctors also use it, off-label, to find those tumours -- especially adrenal gland tumours called pheochromocytoma.","summary":"Fluorodopa F 18 Injection was approved by FDA in 2019 (NDA 200655, sponsor The Feinstein Institutes for Medical Research) solely for PET imaging of dopaminergic nerve terminals in adults with suspected Parkinsonian syndromes; that is a neurological indication, not an oncological one, and it is the only indication on the US label. The recommended dose is 185 MBq (5 mCi) IV.\n\nIn oncology, 18F-FDOPA is used off-label, but with strong evidence and explicit guideline support: the 2019 EANM/SNMMI procedure standard for phaeochromocytoma and paraganglioma names 18F-FDOPA (alongside 123I-MIBG) as a first-line tracer, ahead of 68Ga-DOTATATE and 18F-FDG. In a prospective head-to-head study of 97 patients, FDOPA detected all 55 confirmed pheochromocytomas versus 25 of 55 for 68Ga-DOTATOC (sensitivity 100% vs 49%, p<0.0001), though DOTATATE-family tracers retain an edge for extra-adrenal and SDHx-related metastatic disease. FDOPA is also used, again off-label, in brain tumour imaging (glioma grading and recurrence, alongside FET) under joint EANM/EANO/RANO/SNMMI amino-acid PET guidelines.","status":"approved","asOf":"2026-09-22","links":[{"label":"FDA label: Fluorodopa F 18 Injection","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf"},{"label":"Prospective comparison of 18F-FDOPA and 68Ga-DOTATOC PET/CT in pheochromocytoma/paraganglioma (2023)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10728412/"},{"label":"EANM/SNMMI 2019 practice guideline for radionuclide imaging of phaeochromocytoma and paraganglioma","url":"https://snmmi.org/common/Uploaded%20files/Web/Clinical%20Practice/Procedure%20Standards/2019/EANM%20SNMMI%20guideline%20on%20radionuclide%20imaging%20of%20phaeochromocytoma%20and%20paraganglioma.pdf"}],"tags":["amino acid PET","off-label oncology use","PPGL"],"related":["cu-64-dotatate","ga-68-dotatoc","i-123-mibg","f-18-fet","f-18","ga-68","i-123"],"indications":["pheochromocytoma-paraganglioma","metastatic-ppgl","neuroendocrine","glioblastoma"],"sections":[],"technologies":["pet","pet-ct"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"PET tracer","mechanism":"A fluorinated analogue of L-DOPA that is taken up by the amino-acid transport system and converted by aromatic L-amino-acid decarboxylase (AADC) into a trapped dopamine analogue. Dopaminergic neurons take it up for the FDA-approved neurological indication; the same AADC pathway is highly active in cells of neural-crest and neuroendocrine origin, which is why the tracer also concentrates strongly in pheochromocytoma, paraganglioma and other well-differentiated neuroendocrine tumours.","approvals":[{"region":"US","year":2019,"indication":"PET imaging to visualise dopaminergic nerve terminals in the striatum in adults with suspected Parkinsonian syndromes (neurological indication; oncology use is off-label)"}],"mechanismSteps":[],"dosing":{"route":"Intravenous injection over 1 minute","schedule":"185 MBq (5 mCi) in adults","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf"},"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/f-18-fdopa/","neighbours":{"drug":[{"id":"cu-64-dotatate","kind":"drug","name":"Copper-64 dotatate","route":"/drugs/cu-64-dotatate/"},{"id":"f-18-fet","kind":"drug","name":"Floretyrosine F-18 (FET)","route":"/drugs/f-18-fet/"},{"id":"ga-68-dotatoc","kind":"drug","name":"Gallium-68 edotreotide (DOTATOC)","route":"/drugs/ga-68-dotatoc/"},{"id":"i-123-mibg","kind":"drug","name":"Iobenguane I-123","route":"/drugs/i-123-mibg/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"},{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"},{"id":"i-123","kind":"isotope","name":"Iodine-123","route":"/isotopes/i-123/"}],"indication":[{"id":"glioblastoma","kind":"indication","name":"Glioma & glioblastoma","route":"/indications/glioblastoma/"},{"id":"metastatic-ppgl","kind":"indication","name":"Metastatic pheochromocytoma and paraganglioma","route":"/indications/metastatic-ppgl/"},{"id":"neuroendocrine","kind":"indication","name":"Neuroendocrine tumours","route":"/indications/neuroendocrine/"},{"id":"pheochromocytoma-paraganglioma","kind":"indication","name":"Pheochromocytoma and paraganglioma (PPGL)","route":"/indications/pheochromocytoma-paraganglioma/"}],"technology":[{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"}]}}