18F-DOPA

also known as Fluorodopa F 18 · 18-Fluoro-DOPA · 18-labeled L-fluorodeoxyphenylalanine · 18F-fluoro-dihydroxyphenylalanine · 6-[18F]fluorolevodopa (U.S. Pharmacopeia) · F-DOPA · Fluorodopa 18F (International Non-Proprietary Name) · Fluorodopa F 18 (CAS Number 75290-51-6)

Diagnostic / imaging agent

Investigated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · University of Alberta · Alberta Health services · Baylor College of Medicine · Children's Hospital of Philadelphia · Cook Children's Health Care System
+6 more
· Erik Mittra · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Food and Drug Administration (FDA) · Mayo Clinic · National Cancer Institute (NCI) · University of Pennsylvania

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	FLUORODOPA F18	—	2019-10-10	fda.gov ↗

Trials 10

today

US approved 2019

NCT06667726 · Ph 2 NCT04706910 · Ph 3 NCT03042416 · Ph 3 NCT02175745 · not/applicable NCT02019706 · Ph 2 NCT02021604 · Ph 1 NCT01468454 · Ph 2 NCT00001849 · Ph 2 NCT00001277 · Ph 2

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT02021604	Oct 2013 → Jan 2028 expected	congenital isolated hyperinsulinism, pancreatic insulinoma	Cook Children's Health Care System	Recruiting	No outcome recorded
Phase 25 trials
Phase 2	NCT06667726	Mar 2026 → May 2028 expected	brain cancer	Mayo Clinic	Recruiting	No outcome recorded
Phase 2	NCT02019706	Feb 2014 → Dec 2030 expected	ectopic Cushing syndrome	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Recruiting	No outcome recorded
Phase 2	NCT01468454	Jan 2009 → Jun 2014	congenital isolated hyperinsulinism	Children's Hospital of Philadelphia	Completed	No outcome recorded
Phase 2	NCT00001849	May 1999 → Apr 2019	ectopic Cushing syndrome	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	No outcome recorded
Phase 2	NCT00001277	Dec 1993 → Mar 2020	hypercalcemia disease, multiple endocrine neoplasia type 1	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 32 trials
Phase 3	NCT04706910	Jan 2021 → Dec 2027 expected	Lewy body dementia, Parkinson disease, brain neoplasm, congenital isolated hyperinsulinism +2	University of Alberta	Recruiting	No outcome recorded
Phase 3	NCT03042416	Jun 2017 → Mar 2021	Parkinson disease, brain glioma, congenital isolated hyperinsulinism, neuroblastoma +1	University of Alberta	Completed	No outcome recorded
Phase not applicable1 trial
—	NCT02175745	Dec 2014 → Aug 2015	adult anaplastic ependymoma, adult brainstem glioma, adult glioblastoma, adult oligodendroglioma +17	Erik Mittra	Terminated	No outcome recorded
Phase not stated1 trial
—	NCT02533219	—	congenital isolated hyperinsulinism	Baylor College of Medicine	No longer available	No outcome recorded
Comparator or background therapy1 trial
Phase 2	NCT05781321 Background	Mar 2023 → Jul 2026 overdue	glioblastoma	Mayo Clinic	Active not recruiting	No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

Field	Value	Cited text
Known as	18F-DOPA	“Fortunately, \[18F\]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia.” NCT02533219 ↗ 7 “1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA” NCT01468454 ↗ NCT02019706 ↗ NCT04706910 ↗ NCT01468454 ↗ NCT00001849 ↗ NCT03042416 ↗ NCT00001277 ↗
Known as	18-Fluoro-DOPA	“For diagnostic failure, selective utilization of 18-Fluoro-DOPA PET/CT scanning, arterial stimulation/venous sampling, or transhepatic portal venous sampling were successful in...” PMID 24314196 ↗ Dec 2013
Known as	18-labeled L-fluorodeoxyphenylalanine	“radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA)” NCT01468454 ↗
Known as	18F-fluoro-dihydroxyphenylalanine	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02175745 ↗
Known as	6-[18F]fluorolevodopa (U.S. Pharmacopeia)	“6-[18F]fluorolevodopa (U.S. Pharmacopeia)” NCT02021604 ↗
Known as	F-DOPA	“radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA)” NCT01468454 ↗
Known as	Fluorodopa 18F (International Non-Proprietary Name)	“Fluorodopa 18F (International Non-Proprietary Name)” NCT02021604 ↗
Known as	Fluorodopa F 18	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05781321 ↗ 2 NCT06667726 ↗ NCT02021604 ↗
Known as	Fluorodopa F 18 (CAS Number 75290-51-6)	“Fluorodopa F 18 (CAS Number 75290-51-6)” NCT02021604 ↗
Modality	Diagnostic / imaging agent	“Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA” NCT00001277 ↗
Route	Intravenous	“will be injected intravenously into the subject” NCT02021604 ↗