18F-Fluoroestradiol

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TRACER INFORMATION AND INDICATION

18F Cerianna was given FDA approval in 2020 for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Since this tracer is only beneficial in ER-positive lesions, tissue biopsy should be used to confirm recurrence and verify pathology as Cerianna is not useful in other pathologies including HER2 and progesterone receptor positive tumors.

The main goal of using Cerianna is to help determine appropriate treatment options for those with breast cancer. Imaging may be done in conjunction with 18F FDG imaging for lesion classification.

CONTRAINDICATIONS

None

PATIENT PREPARATION

The patient should be well hydrated both before and after Cerianna injection. In addition, Cerianna imaging should preferably occur before the patient begins systemic endocrine therapies. Some of these therapies, such as tamoxifen and fulvestrant, could reduce the uptake of Cerianna as they may block ER for up to 8 and 28 weeks.

At this time, there are no available data on Cerianna use in pregnant women as well as use in pediatric patients.

RADIOPHARMACEUTICAL

In adults, the recommended amount of radioactivity to be administered is 222Mbq (6mCi) administered over 1 to 2 minutes. The total volume of the injection should be 10mL or less.

The recommended start time post-injection is 80 minutes.

IMAGING PROTOCOL AND ACQUISITION PARAMETERS

Instruct patient to void prior to imaging and change clothing if necessary.

Imaging parameters are typically from the vertex to knee, with the patient lying supine and arms raised above their head.

Scan duration usually falls within 20 to 30 minutes. Timing should be checked with attending for optimal image quality.

BIODISTRIBUTION

Normal uptake of Cerianna includes the liver, ovaries, and uterus. Elimination of Cerianna occurs by urinary and biliary excretion.

IMAGE INTERPRETATION

All lesions with an uptake greater than background are considered as positive, meaning there is evidence of the presence of estrogen receptors ligand-binding function of estrogen receptors. The most commonly used SUV threshold for calling a lesion positive is 1.5, with a range from 1 to 1.8. However, interpretation based solely on quantitative measures should be avoided as many factors such as recent treatments and the partial volume effect can alter SUV values.

In addition, it should be noted that the uptake of Cerianna is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast. Cerianna should not be used in lieu of biopsy.

REIMBURSEMENT

Regarding the Radiopharmaceutical Coding, For claims with a date of service January 1, 2021 and beyond and for all payers in all settings, use A9591 Fluoroestradiol F-18, diagnostic, 1 millicurie (NDC #:72874-0001-0)

References

CERIANNA (F-18 Fluoroestradiol Injection)[package insert]. Marlborough, MA. Zionexa US Corp. 2022.

CERIANNATM (F-18 labeled Fluoroestradiol, Injection) - SNMMI. (n.d.). https://www.snmmi.org/IssuesAdvocacy/QandADetail.aspx?ItemNumber=33939

Zionexa US Corp. Cerianna Full prescribing information. https://www.cerianna.com/wp-content/uploads/2020/05/cerianna-prescribing-information.pdf. Revised July 2020