Fluoroestradiol F18

(Cerianna®)

Fluoroestradiol F18

Drug updated on 5/17/2024

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.

Summary
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  • Fluoroestradiol F18 (Cerianna) is indicated for use with positron emission tomography (PET) imaging to detect estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
  • The information was derived from three systematic reviews/meta-analyses on Cerianna and its usage in PET imaging for detecting ER-positive lesions, particularly in those with recurrent or metastatic breast cancer.
  • Cerianna has a favorable safety profile. Pain at the injection site is considered related more to mechanical injury from needle injection than to the administration of radioactive material itself, indicating that this diagnostic tool carries less risk compared to invasive biopsies.
  • In terms of effectiveness, Cerianna demonstrated high diagnostic accuracy for breast cancer detection with pooled sensitivity and specificity rates of 0.86 and 0.85, respectively; it also effectively predicts treatment response concerning endocrine therapy in these patients.
  • Compared against other solid tumors like endometrial cancer or uterine sarcoma, lower mean standardized uptake value was observed for breast cancer lesions; however, pooled detection rates were comparable between FES PET imaging using Cerianna and the widely used 18F-FDG PET imaging method.
  • While primarily focused on those with recurrent or metastatic breast cancers where accurate lesion detection can significantly influence treatment strategies due to its non-invasive nature coupled with high diagnostic accuracy over traditional biopsy methods, there is mention of potential broader applicability across different types of ER-positive solid tumors such as ovarian and uterine cancers, although specific metrics are less defined within these subgroups according reviewed studies.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses