Drug updated on 9/5/2024
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.
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Summary
- 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 Title | Year | Source |
---|---|---|
Cerianna (fluoroestradiol F 18) Prescribing Information. | 2023 | 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 18F-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 |