Drugs / Sodium Fluoride F-18

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FLUORINE F-18 1972-02-24 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06914999 Dec 2024 → Aug 2026 overdue hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oropharynx squamous cell carcinoma Emory University Recruiting No outcome recorded
Phase 13 trials
Phase 1 NCT03619655 Nov 2019 → Nov 2022 prostate cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 1 NCT03497377 May 2016 → Apr 2020 metastatic prostate carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 1 NCT02429804 Apr 2015 → May 2017 hormone-resistant prostate carcinoma, metastatic carcinoma in the bone, metastatic prostate carcinoma Stanford University Terminated No outcome recorded
Phase 22 trials
Phase 2 NCT03173924 Jun 2017 → Feb 2028 expected metastatic prostate carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT01237054 Oct 2010 → Aug 2011 monoclonal gammopathy of uncertain significance, smoldering plasma cell myeloma National Cancer Institute (NCI) Completed No outcome recorded
Phase 31 trial
Phase 3 NCT05614518 Mar 2021 → Jun 2022 musculoskeletal system cancer HTA Co., Ltd. Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT04981509 Background Jun 2022 → Dec 2027 expected hereditary leiomyomatosis and renal cell cancer, papillary renal cell carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT01240551 Comparator Nov 2010 → May 2013 prostate cancer National Cancer Institute (NCI) Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Sodium Fluoride F-18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04981509
2

NCT06914999

NCT05614518

Known as 18F-NaF ClinicalTrials.gov intervention name — accepted as the source's own label NCT03173924
2

NCT03619655

NCT03497377

Known as F-18 NaF “The patient will receive 5mCi of F-18 NaF IV (intravenous) bolus” NCT01237054
1

NCT01240551

Known as F-18 sodium fluoride F-18 sodium fluoride (NaF) is a PET radiopharmaceutical” NCT01240551
Known as Fluorine F 18 Sodium Fluoride ClinicalTrials.gov intervention name — accepted as the source's own label NCT02429804
Known as NaF “F-18 sodium fluoride (NaF) is a PET radiopharmaceutical” NCT01240551
1

“Sodium Fluoride (NaF)-PET/CT imaging” NCT03497377

Known as Sodium Fluoride Sodium Fluoride (NaF)-PET/CT imaging” NCT03497377
Modality Diagnostic / imaging agent “a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT)” NCT01237054
Route Intravenous “F-18 NaF IV (intravenous) bolus” NCT01237054