Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; 148 MBq/mL to 3,700 MBq/mL [4 mCi/mL to 100 mCi/mL]) |
| Drug Class | Radioactive 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
- Fluoroestradiol F18 (Cerianna) is used 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.
- A systematic review and meta-analysis of eight studies evaluated the diagnostic accuracy and safety of Cerianna, specifically its effectiveness in assessing estrogen receptor expression in patients who have recurrent or metastatic breast cancer.
- The population under study were patients suffering from recurrent or metastatic breast cancer, particularly those expressing ER-positive lesions.
- In terms of safety, it was found that any reported pain at the injection site was likely due to mechanical injury from needle injection rather than administration of radioactive materials; thus indicating that Cerianna is safe for use.
- The pooled analysis revealed a sensitivity and specificity rate each at 0.86 and 0.85 respectively, suggesting high diagnostic accuracy when using Cerianna for detecting ER-positive lesions in this patient group compared to other drugs available on market.
- Given these findings along with consideration towards anatomical sites where only invasive tests are possible, fluoroestradiol F18 has been deemed highly effective clinically.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cerianna (fluoroestradiol F18) Prescribing Information. | 2022 | GE Healthcare, Wauwatosa, WI |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| 18F-fluoroestradiol positron emission tomography in patients with breast cancer: a systematic review and meta-analysis. | 2023 | Revista da Associação Médica Brasileira |
| The application of 18 F-FES PET in clinical cancer care : a systematic review. | 2023 | Clinical Nuclear Medicine |
| Safety and effectiveness of F-18 fluoroestradiol positron emission tomography/computed tomography: a systematic review and meta-analysis. | 2021 | Journal of Korean Medical Science |