SAN ANTONIO, Dec. 11, 2018 /PRNewswire/ -- Seno Medical
Instruments, Inc. (Seno Medical), the leader in new technology for
breast cancer diagnosis using opto-acoustic (OA/US) imaging to
differentiate benign from malignant masses, reported results of a
study demonstrating that morphologic and functional OA/US features
provide a non-invasive approach to helping distinguish breast
cancer molecular subtypes. The data were presented on November 26, 2018 at the Radiological Society of
North America (RSNA) 2018 Annual
Meeting in Chicago and the
abstract was featured as one of three High Impact Clinical Trials
selected for this special session.
"It has been known for some time that breast cancers with
differing receptor expression and gene amplification profiles have
different risk factors for disease progression, as well as
different preferential organ sites of metastases and therapeutic
response. Nevertheless, large-scale gene expression profiling from
biopsy samples is not currently feasible," said Thomas
Stavros, MD, Chief Medical Officer of Seno Medical. "We
previously hypothesized that more aggressive molecular subtypes
might be detectable based on their OA/US feature scores. The
results of intense comparison of our histological and OA/US imaging
demonstrate and underscore the potential value of OA/US as a novel
and non-invasive tool for gleaning critical information that may
help to guide and optimize treatment for women with breast cancer.
The importance of these data is underscored by their inclusion in
the High Impact Clinical Trial category, and we are pleased that
RSNA selected our OA/US technology for this honor for the second
year in a row."
There are four distinct main molecular subtypes of breast
cancer, which are defined based on the presence of hormone
receptors (estrogen [ER] and progesterone [PR]) with or without
human epidermal growth factor receptor 2 (HER2) protein
overexpression or extra copies of the HER2 gene, and elevation of
the ki67 proliferation marker. The four subtypes are:
- Luminal A (LumA; ER+/HER2−negative, ki67<14%);
- Luminal B (LumB; ER+/HER2-negative, ki67≥14%, or
ER+/HER2+);
- HER-2 amplified or positive (HER2+; ER-negative, HER2+)
and
- Triple Negative Breast Cancer (TNBC); ER and
PR-negative/HER2−negative).
The study investigated the potential role of functional OA/US
imaging-derived hemoglobin de-oxygenation and angiogenesis feature
scoring combined with conventional gray-scale ultrasound (US) in
non-invasively diagnosing these breast subtypes.1 A
total of 2,105 women with suspicious breast masses who underwent
pre-biopsy OA/US imaging using Seno's Imagio® OA/US
Breast Imaging System at 16 clinical sites between December 2012 and September 2015 were included in the study.
Lesions revealing invasive breast cancer on needle biopsy were
retrospectively reviewed, and seven blind readers scored the
internal (OAINT) and external (OAEXT) OA/US features of identified
cancers. The ratio of total internal to total external US and OA/US
feature scores (RInt/Ext) was derived. Tumor hormone receptor (ER
and PR), and HER2 status, and available ki67(%) labeling index were
derived from pathology specimens. Key findings from the study
include:
- Of 653 invasive cancers, 537 (82.2%) were ER+ and 111 (17%)
were ER-negative, with ER data missing for 5 (0.8%) patients.
- ER+ cancers had significantly higher OAEXT (p<0.001), with
lower OAINT (p<0.05) and RInt/Ext (p<0.001) compared with
ER-negative ones.
- Of 532 patients with available pathologic molecular subtype,
186 (35.0%) were LumA, 244 (45.9%) were LumB, 79 (14.8%) were TNBC
and 23 (4.3%) were HER2+.
- All OAEXT scores were lower in TNBC compared with LumA
(p<0.001), whereas OAINT vessels and total scores were lower in
LumA compared with TNBC (p<0.05).
- The mean RInt/Ext was significantly higher in TNBC (1.7, SD ±
0.7) compared with LumB (1.3, SD ±0.5) and LumA (1.2, SD ± 0.5)
subtypes (p<0.001), but not significantly different from HER2
(1.5, SD ±0.6).
- RInt/Ext feature scores helped distinguish LumA vs. LumB
(p<0.05), LumA vs. HER2+ (p<0.05, LumA vs. TNBC (p<0.001)
and LumB vs. TNBC (p<0.001.
The data demonstrate that morphologic and functional OA/US
features may provide a non-invasive approach to help distinguishing
breast cancer molecular subtypes. The study authors conclude that
data from such subtype analyses could potentially facilitate
clinical management decisions.
"The exciting finding in this study is OA/US imaging features
may serve as imaging biomarkers that predict molecular phenotypes.
This not only helps establish the diagnosis of breast cancer, but
also distinguishes cancers with poor prognosis from those with good
prognosis non-invasively – using no radiation, contrast or a need
for biopsy," said Basak E. Dogan, MD, University of Texas Southwestern Medical Center,
presenter at RSNA and the first author of the study. "This is an
important step forward to non-invasively optimize treatment
regimens in keeping with the unique molecular profile of each
woman's cancer. Furthermore, it is a great opportunity to assess
the cancer three dimensionally instead of making treatment
decisions based on small biopsy samples. OA/US has the potential to
improve treatment outcomes for women with invasive breast
cancer."
The Imagio® OA/US Breast Imaging System is the
subject of a U.S. PMA filing with the FDA and does have European CE
Mark.
About Seno Medical Instruments, Inc.
Seno Medical
Instruments, Inc. is a San Antonio,
Texas-based medical imaging company committed to the
development and commercialization of a new modality in cancer
diagnosis: opto-acoustic imaging. Seno Medical's Imagio®
OA/US Breast Imaging System fuses opto-acoustic technology with
ultrasound (OA/US) to generate fused real-time functional and
anatomical images of the breast. The opto-acoustic images provide a
unique blood map around breast masses while the ultrasound provides
a traditional anatomic image. Through the appearance or absence of
two hallmark indicators of cancer – angiogenesis and deoxygenation
– Seno Medical believes that the Imagio OA/US breast imaging system
will be a more effective tool to help radiologists confirm or rule
out malignancy than current diagnostic imaging modalities – without
exposing patients to potentially harmful ionizing radiation
(x-rays) or contrast agents. To learn more about Seno Medical's
OA/US imaging technology and applications, visit
www.SenoMedical.com.
Media Contact
Erich
Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com
1 Moy L, Dogan BE, Menezes GD, Neuschler EI,
Butler RS, Stavros AT, et al. Optoacoustic imaging (OA) is helpful
in predicting breast cancer molecular subtypes. Presented at RSNA
2018 on November 26. Abstract
SPS126B.
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