Fluoroestradiol F 18

(Cerianna®)

Fluoroestradiol F 18

Drug updated on 10/28/2024

Dosage FormInjection (intravenous; 148 MBq/mL to 3,700 MBq/mL [4 mCi/mL to 100 mCi/mL])
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • The pooled sensitivity and specificity of F-18 fluoroestradiol (F-18 FES) PET (positron emission tomography)/CT for assessing estrogen receptor expression in patients with recurrent or metastatic breast cancer were 0.86 and 0.85, respectively, demonstrating high diagnostic accuracy.
  • The study focused specifically on patients with recurrent or metastatic breast cancer, with no further subgroup analyses provided.
  • No comparative effectiveness data with other drugs were available in the study.
  • The primary safety concern reported for F-18 fluoroestradiol (F-18 FES) PET/CT was injection site pain, which was attributed to mechanical injury from the needle rather than the radioactive material itself.
  • No significant adverse effects were reported in the study, and the test was deemed safe overall.

Product Monograph / Prescribing Information

Document TitleYearSource
Cerianna (fluoroestradiol F 18) Prescribing Information.2024GE Healthcare., Wauwatosa, WI

Systematic Reviews / Meta-Analyses