Ultra-Low Frequency Transmitted Ultrasound Breast Imaging vs DBT (Digital Breast Tomosynthesis): A Patient-Reported Outcome Study

Abstract

Elaine Iuanow,1 Emily A Pickup,2 Bilal Malik,1 Julie Doehrmann,2 Fernando A Huyke,3 Rachel Ducker,1 John Klock1 1QT Imaging Inc, Novato, CA, USA; 2CODE Technology, Minneapolis, MN, USA; 3TRIA Orthopedics, Minneapolis, MN, USACorrespondence: Elaine Iuanow, Email [email protected]: Breast cancer screening remains a challenge in the United States. Many women do not get a mammogram because of pain associated with the exam, radiation exposure, false-positive results, and additional costs. Others who may benefit from annual screening do not qualify because of young age and radiation risk. We hypothesize that a novel volumetric transmitted breast ultrasound, Quantitative Transmission (QT) Scan may encourage more women to have annual breast cancer screening. Assessing results from patient-reported outcomes (PROs) may predict the value of newer, more desirable screening technologies.Participants and Methods: Pre- and post-menopausal women who qualified for breast cancer screening were enrolled in a prospective trial of Quantitative Transmission (QT Scan) vs traditional mammography via Digital Breast Tomosynthesis (DBT) Clinical Trials.gov NCT 03052166. These women completed questionnaires to assess their experiences with QT Scan and DBT. Associations between QT Scan or DBT and differences in PRO scores were examined.Results: A total of 430 subjects completed the PRO instrument analyzed. A total of 36 questions were asked, 34 were paired for both QT and DBT and two were asked regarding exclusively the QT Scan. Physical discomfort, perceptions of safety and low efficacy, false-positive results and additional out-of-pocket expenses were concerns identified as highest risk for opting out of screening mammography (differences between 2.1 and 2.9 indicate significant differences between means and standard deviations using the Cohen’s d statistic). Student’s T-test shows a significance level of < 10 − 10. Statistically significant differences in PROs between QT Scan and DBT were observed by 14 of the 17 paired experience questions (p< 0.001).Conclusion: Significant differences in PROs were found between QT scan and DBT, indicating women have significantly more negative experiences with traditional mammography via DBT and are less inclined to undergo screening mammography. Identification of PRO differences could be used to help identify a more desirable breast cancer screening modality.Keywords: breast screening, transmission ultrasound, patient-related outcomes

Keywords

• breast screening
• transmission ultrasound
• patient related outcomes