Developing & Validating a Clinical Decision Support Tool for ER-targeted PET Imaging with 16α-18F-Fluoro-17β-Fluoroestradiol

Abstract

BackgroundEstrogen receptor (ER) status in breast cancer (BC) is routinely determined by immunohistochemistry (IHC); however, this technique is not without limitations, including false results. Imaging of CeriannaTM (fluoroestradiol F18) injection provides high diagnostic accuracy of ER expression, supplementing information from biopsy. A Clinical Decision Support (CDS) tool was developed to better assess its clinical usefulness in metastatic and recurrent breast cancer management. This study evaluated a conceptual tool that reflects clinical practice variables. MethodsIndividual patient characteristics - candidacy for therapeutic treatment and rate of recurrence - determined initial eligibility. The CDS tool uses rules (IF-THEN statements) to produce an output on the diagnostic accuracy of ER status based on tumor burden, anatomical location(s) of metastasis, heterogeneity, and confidence in sample collection & pathology accuracy (CSC & PA). An Excel-based probability decision tree calculates the accuracy of ER expression. Results360 oncologists in the United States participated in the survey study. 223 respondents identified as medical oncologists (62%), 77 as clinical oncologists (21%), and 60 as hematologic oncologists (17%). 93% of respondents found the CDS tool intuitive and easy to follow with medical and clinical oncologists favoring the tool more than hematologic oncologists. Individual CDS attributes - clinical criteria, diagnostic comparator, true positive and true negative, patient inclusion and exclusion, and clinical patient level inputs - were tested with overall positive feedback. ConclusionsBased on respondent feedback, further development of CDS tools are warranted for potential use in patients’ diagnostic workup. Micro abstractCorrect identification of estrogen receptor (ER) status in breast cancer is critical to optimal treatment decisions. While ER status is routinely determined by biopsy and immunohistochemistry (IHC), this technique may yield false positive or negative results. Cerianna (fluoroestradiol F18) injection provides high diagnostic accuracy of ER expression, supplementing the information obtained by IHC. A Clinical Decision Support tool was developed to help identify the contribution that Cerianna may contribute to the management of metastatic and recurrent breast cancer. This study incorporated the feedback of 360 Oncologists representing several sub-specialties, settings of care, and other variables. The results confirmed the validity of the CDS tool concluding that it resonates with clinical practice today, is complete and would be used in clinical practice.