QT Imaging, Inc., a medical device company focused on the development and clinical adoption of novel products for body imaging, announced the findings of a study analyzing changes in breast glandular and ductal volume during the menstrual cycle for pre-menopausal, peri-menopausal, and post-menopausal women.
The results showed that glandular tissue has greater menstrual cycle variation in pre-menopausal breasts than in post-menopausal breasts, whereas ductal tissue does not have significantly more variation in pre-menopausal breasts than in post-menopausal breasts. The study, done in collaboration with the Dr. Susan Love Foundation, analyzed over 400 images of 24 women without any identified breast malignancy during their menstrual cycle.
The FDA-cleared QT Scanner was used to collect routine breast scans on women ages 18 to 71. These women were scanned weekly from six to ten times through at least two months of observation. The scanner was able to directly determine volumetric breast density and separate glandular and ductal tissue volumes. The glandular and ductal tissue variations for pre- and post-menopausal breasts were compared. This study provides a more accurate description of tissue changes during the menstrual cycle. These observations show quantitatively different behavior in glandular and ductal tissue in vivo and represent the first time that such an observation has been made.
Studies of normal glandular and ductal breast anatomy are important as they enable delineation of what is normal as a woman passes through puberty, menstruation, pregnancy, post-partum nursing, and menopause. Additionally, breast tissue glandular and ductal volumes can be important to measure in women on various hormone treatments for benign and malignant conditions, cancer prevention treatments and treatments of hormone-receptor positive cancers with hormones or SERMs. These results were reported at the SPIE Medical Imaging Conference, Feb. 2022, in San Diego.
Teresa Soler de Lara, Director of Research of the Dr. Susan Love Research Foundation, says “the study carried out by QT Imaging helps us understand the changes involved in the breasts during the menstrual cycle. This might ultimately aid and make better the early detection of the mechanisms that contribute to the development of breast cancer, making screening a more accurate process for all women.”
“Along with previously published comparative anatomic studies in breasts, these results demonstrate the viability of low frequency transmitted sound volography as a low-cost, high-resolution imaging modality of important clinical value,” said John Klock, MD, CEO and CMO at QT Imaging.
QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner, and the National Institutes of Health (NIH) has awarded over $15 million in funding to support QT Imaging research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.
The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.
Dr. Susan Love Foundation for Breast Cancer Research is dedicated to achieving a future without breast cancer by igniting visionary, collaborative research, and a distinctive approach to education.
For more information visit qtimaging.com.