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

Background: Estrogen 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 Cerianna ^TM (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.
Methods: Individual 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.
Results: 360 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.
Conclusions: Based on respondent feedback, further development of CDS tools are warranted for potential use in patients' diagnostic workup.
Competing Interests: Disclosure This study was funded by GE HealthCare. The funder provided support in the form of salaries for authors and funded the data collection executed by Eversana but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.
(Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)