Stress strain imaging for detection and characterization of endometriosis, adenomyosis and uterine fibroids

Advanced Tactile Imaging, Inc., Trenton NJ

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Abstract

Project Summary Endometriosis affects 6-10% of women of reproductive age, with prevalence of 20-50% in infertile women, and 71-87% of women with chronic pain. The incidence of adenomyosis is reported as 28.9 per 10,000 women. Adenomyosis is detected in 27% of hysterectomy materials in benign gynecological surgery. It leads to abnormal uterine bleeding, pelvic pain, pelvic mass, and infertility. Uterine fibroids are the most common benign tumors of the reproductive system found in 15–65% of women. Like adenomyosis, uterine fibrosis can lead to complaints of vaginal bleeding, pelvic pain, and infertility, depending on their location. Unfortunately, there is often a delay in the diagnosis of such conditions. In patients aged 18–45 years, the average delay is 6.7 years. Early referral, identification of disease and treatment may mitigate pain, prevent disease progression, and thus preserve fertility. Barriers to early diagnosis include the high cost of diagnosis and presentation of confounding symptoms. Thus, a non-invasive tool to diagnose such conditions could facilitate earlier intervention that could ultimately improve quality of life and preserve fertility. In the Phase I research, a unique probe capable of tactile and ultrasound imaging will be designed (Aim 1) and its imaging performance of endometriosis, adenomyosis, and uterine fibroids will be explored in a feasibility study with 30 patients (Aim 2). It will be a new device for stress-strain imaging of the targeted areas in the female pelvic floor and recognition of targeted diseased conditions. Stress data will be provided by a 2D pressure (tactile) sensor array and strain data, and anatomical images will be supplied by a high-definition ultrasound. This data combination allows biomechanical mapping of the soft tissues in absolute scale. The scientific premise behind this approach is that practically all soft tissue disease conditions change their viscoelastic properties. The proposed approach is designed to shorten the time to diagnosis, improve accessibility, safety, convenience, and costs of the diagnosis.