Fluoroestradiol F18

(Cerianna®)

Cerianna®

Drug updated on 9/5/2024

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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  • Cerianna (fluoroestradiol F18) is 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.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-3]
  • The FES PET imaging demonstrated a pooled detection rate of 0.80 for breast cancer and 0.84 for ovarian cancer. The FES SUV mean for endometrial cancer was reported between 3.4-5.3, which is higher compared to breast cancer (2.05) and uterine sarcoma (1.1-2.6).
  • F-18 FES PET/CT exhibited a sensitivity of 0.86 and a specificity of 0.85 in assessing estrogen receptor expression in patients with recurrent or metastatic breast cancer.
  • FES PET imaging and [18F]FDG PET imaging had similar detection rates for breast and ovarian cancer, with FES thresholds detecting 11.1% to 45% of ER heterogeneity, particularly effective in uterine cancer prognosis.
  • The safety profile of F-18 FES PET/CT was primarily marked by injection site pain, attributed to mechanical injury from the needle, with no significant adverse effects reported related to the radioactive material.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Cerianna (fluoroestradiol F 18) Prescribing Information.2023GE Healthcare., Wauwatosa, WI

Systematic Reviews / Meta-Analyses