Exploring the Utility of Optoacoustic Imaging in Differentiation of Benign and Malignant Breast Masses: Gen 2 Study

Rationale and Objectives

The combination of functional biologic data and imaging appearance has the potential to add diagnostic information to help the radiologist evaluate breast masses in an efficient, effective, and cost-conscious manner. This is the first clinical evaluation of the Gen 2(Model 9100, 8101) Imagio® System to assess image quality with both the stand-alone internal ultrasound (IUS), ultrasound-only transducer, and the Optoacoustic/Ultrasound (OA/US) duplex probe 1, 2. This study assesses palpable and non-palpable breast abnormalities in patients who are referred for diagnostic breast ultrasound work-up. This study is intended to confirm the clinical acceptability of modifications made to the Imagio® System ultrasound component following Premarket Approval (PMA) of the Imagio® Gen 1 version.

Materials and Methods

This prospective, single-arm, non-randomized study included 38 patients presenting with a palpable lump and/or imaging abnormality detected at a single investigational site. Each patient had the breast, and if indicated, the axillary lymph nodes imaged with the Gen 2 Imagio® system.

Results

For patients with SenoGram®-predicted Likelihood of Malignancy (LOM) and pathology available (N = 23), observed sensitivity was 100.0% (9/9) with a confidence interval of (66.4%, 100.0%), using a SenoGram®-predicted False Negative Rate (FNR) cut-off of ≤ 2%. Observed specificity was 64.3% (9/14) (Confidence Interval: 35.1%, 87.2%), using a SenoGram®-predicted FNR cut-off of ≤ 2%. At 98% fixed sensitivity, the specificity (fSp) for OA/US + SG was 100.0% while it was 0.0% for IUS. The absolute gain in fSp was 100.0%.

Conclusion

Combining structure with morphology can increase specificity without decreasing sensitivity in a real-world setting.