Summary: Appropriate Use Criteria for Estrogen Receptor–Targeted PET Imaging with 16α-¹⁸F-Fluoro-17β-Fluoroestradiol

Abstract

PET imaging with 16α-¹⁸F-fluoro-17β-fluoroestradiol (¹⁸F-FES), a radiolabeled form of estradiol, allows whole-body, noninvasive evaluation of estrogen receptor (ER). ¹⁸F-FES is approved by the U.S. Food and Drug Administration as a diagnostic agent “for the detection of ER-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.” The Society of Nuclear Medicine and Molecular Imaging (SNMMI) convened an expert work group to comprehensively review the published literature for ¹⁸F-FES PET in patients with ER-positive breast cancer and to establish appropriate use criteria (AUC). The findings and discussions of the SNMMI ¹⁸F-FES work group, including example clinical scenarios, were published in full in 2022 and are available at https://www.snmmi.org/auc. Of the clinical scenarios evaluated, the work group concluded that the most appropriate uses of ¹⁸F-FES PET are to assess ER functionality when endocrine therapy is considered either at initial diagnosis of metastatic breast cancer or after progression of disease on endocrine therapy, the ER status of lesions that are difficult or dangerous to biopsy, and the ER status of lesions when other tests are inconclusive. These AUC are intended to enable appropriate clinical use of ¹⁸F-FES PET, more efficient approval of FES use by payers, and promotion of investigation into areas requiring further research. This summary includes the rationale, methodology, and main findings of the work group and refers the reader to the complete AUC document.