Study Finds Opto-Acoustic Imaging During Neoadjuvant Therapy Correlates to Pathologic Response

Study evaluates feasibility of leveraging Seno’s Imagio^® System to detect response earlier during breast cancer therapy.

[San Antonio, TX – December 8, 2023] A limited feasibility study presented at this year’s San Antonio Breast Cancer Symposium (SABCS) found that Seno Medical’s Imagio^® Breast Imaging System using opto-acoustic/ultrasound (OA/US) shows promise in detecting vessel and oxygenation changes preceding tumor volume decrease in patients who are in a trajectory to achieve a tumor pathologic complete response (pCR). Similarly, an increase in OA/US scan scores after cycle 1 may be an important indicator of poor response to chemotherapy, allowing for intervention earlier in the course of therapy.

The poster Changes in Breast Cancer Opto-Acoustic Imaging Features During Neoadjuvant Therapy and Correlation with Pathologic Response: A Feasibility Study was presented on Friday, December 8, by Basak Dogan, MD, director of breast imaging research at the University of Texas Southwestern Medical Center, Department of Radiology, Harold C. Simmons Comprehensive Cancer Center.

The analysis highlights the role OA/US can play in predicting response to neoadjuvant therapy (NAC) by evaluating the OA/US imaging feature changes. The objectives included but were not limited to: (1) identify complete responders (patients who had no residual cancer left after chemotherapy, i.e., pCR) before ultrasound (US) volume changes occur and (2) detect non-responders early in the course of therapy.

Key results of the study include:

• At the end of cycle 1 chemotherapy, the OA/US percentage change in internal hemoglobin (Hb) score (76.4% vs 108.8% in complete vs non-complete responder groups, respectively, p=0.01) had the highest correlation with pCR at surgery
• Changes in all mean OA/US scores from baseline to pre-surgery except peripheral zone radiating vessel score significantly correlated with pCR (p<0.05)
• Multiple individual and total OA/US scores at cycle 1 predicted poor response (RCB-III) status; percent decrease in OA/US Mean Deoxygenated Blush Score at cycle 1 scan was significantly lower in cancers that showed RCB-III (117.8%) vs. complete to moderate response (RCB 0-II) (64.8%), p=0.03 at pathology
• Tumor volume change was not significantly different in pCR vs. non-pCR at cycle 1, mid therapy time points, while there was a significant difference at pre-surgery scan (p<0.003)
• No scan-related Serious Adverse Effects were reported.

The authors concluded, “Our preliminary findings indicate that OA/US-detected vessel and oxygenation changes precede tumor volume decrease in patients who are in a trajectory to achieve pCR (complete response). OA/US shows promise to identify exceptional responders as early as post-cycle 1 therapy. In addition, several OA/US scores at cycle 1 scan significantly correlated with poor response (RCB-III) status, indicating that in vivo tumor oxygenation assessed by OA/US can be used to predict chemotherapy resistance. The I-SPY 2 Trial utilizes a new predictive tool, ‘PreRCB,’ which includes mid-treatment MRI and core biopsy responses to identify patients likely to have a pCR¹. OA/US imaging eliminates the need for contrast use or an invasive biopsy procedure; therefore, may have better acceptance by patients compared to MRI or needle biopsy.”

Imagio^® OA/US technology combines laser optics and grayscale ultrasound to offer functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer — angiogenesis and deoxygenation — the Imagio^® OA/US Breast Imaging System is a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (X-rays) or contrast agents.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022, including its state-of-the-art ultrasound technologies, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

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^{1 Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA; I-SPY 2 Investigators. Adaptive Randomization of Neratinib in Early Breast Cancer. N Engl J Med. 2016 Jul 7;375(1):11-22. doi: 10.1056/NEJMoa1513750. PMID: 27406346; PMCID: PMC5259558.}