SBIR-STTR Award

This application would develop a method of treatment for uterine fibroids, using High Intensity Focused Ultrasound (HIFU). Fibroids, which are benign tumors of the uterus, develop in more than half of all women and are associated with an increased incidence of infertility and risk of endometrial carcinoma. Fibroids represent the most common indication for major surgery in women, accounting for 30 percent of all hysterectomies (removal of the whole uterus). HIFU offers a non-invasive, bloodless method of treatment without the drawbacks of the current methods. A high rate of tumor recurrence exists following drug therapy and even surgical removal of the tumor (myomectomy). Results in an animal model of fibroid tumors show that HIFU can treat tumors completely, with no recurrence. Significant risks such as blood loss, intra-abdominal infection, and damage to vital organs are associated with both myomectomies and hysterectomies. HIFU would require no surgery, as it has been demonstrated in other applications. Currently, the cost of treatment for uterine fibroids is approximately $1,200 for a three-month regimen of drug therapy, and $5,000 to $14,000 for an operation. The investigators hope to develop a method that would be performed in the physician office, requiring no anesthesia and expensive surgery. They believe that image-guided HIFU may provide a valuable option for treatment of fibroids.

High Intensity Focused Ultrasound (HIFU) offers a non-invasive, non-surgical, bloodless, outpatient treatment for uterine fibroid tumors. These tumors develop in over half of all women, and account for approximately 30 percent of all hysterectomies. This proposal will develop an integrated transvaginal HIFU probe and imaging transducer for fibroid treatment. The proximal transvaginal approach facilitates optimal HIFU control, improves aiming and minimizes complications. Phase I of this grant successfully constructed a lab prototype HIFU/Imaging unit, measured the speed and attenuation of sound in excised human fibroids, and established optimal treatment parameters (frequency, intensity and dose). Phase II will utilize several imaging modalities to map numerous in-situ fibroid tumors and evaluate the range of uterine and intervening tissue structures in women, develop an anatomically correct integrated HIFU/Imaging clinical prototype probe, evaluate the safety and efficacy of this treatment in sheep studies and evaluate this probe?s placement and imaging characteristics in humans. This grant will develop the properly shaped HIFU probe and investigate the safety and efficacy of HIFU to treat fibroids in Phase Ill human clinical studies. Dramatic improvements in patient treatment, reduced complication rate, reduction in health care costs, reduced recovery time and preservation of a women?s fertility are the potential results. PROPOSED COMMERCIAL APPLICATION: The goal of this research is to develop a non-surgical, outpatient treatment system for uterine fibroid tumors based upon high intensity focused ultrasound (HIFU). It is anticipated that this treatment will improve patient care, facilitate an alternative to hysterectomy, and result in significantly lower treatment cost. Ultimately, this treatment approach may also provide an option to preserve fertility and improve reproductive outcomes in patients with fibroid tumors.

Thesaurus Terms:
human therapy evaluation, neoplasm /cancer therapy, technology /technique development, ultrasound therapy, uterus neoplasm leiomyoma, method development, neoplasm /cancer surgery bioengineering /biomedical engineering, bioimaging /biomedical imaging, clinical research, computed axial tomography, female, human data, human subject, magnetic resonance imaging, sheep