Image-guided ethyl cellulose ethanol ablation to enable treatment of cervical dysplasia in low and middle-income countries - ABSTRACT Cervical cancer affects the lives of half a million women worldwide each year, and over half of these women die. Preventative solutions that are widely used in wealthy countries are not practical for use in medically underserved regions due to sophisticated technologies and expertise needed to sustain these solutions. Thus, alternative protocols that employ low-cost, simple-to-use technologies are needed to prevent cervical cancer. Our vision is to develop high quality, low-cost interventions that will be effective in low and middle-income countries (LMICs) to address shortcomings of current solutions for cervical cancer prevention. Previously, our team created and successfully launched the Pocket colposcope, a low-cost, portable device to diagnose cervical dysplasia in the primary care setting. However, diagnosis alone will not lead to decreases in cervical cancer mortality if access to point-of-care treatment remains limited. Recently, thermocoagulation has gained acceptance for ablation of cervical dysplasia as it does not require consumables (continuous supply of pressurized liquid nitrogen for cryotherapy) or a stable power supply (for LEEP). While thermocoagulation effectively ablates superficial layers of cervical lesions (≤3.5 mm), it is unable to ablate deeper, more advanced lesions. To develop a complementary therapeutic approach to thermocoagulation, the University of Maryland (UMD) has partnered with Calla Health Foundation under phase I and phase II SBIR funding (R44CA257303) to establish an injectable low-cost ablative therapy based on injection of a ubiquitous agent, ethanol to treat cervical dysplasia, which can be delivered at deeper depths. Specifically, we developed a new formulation of ethanol using a polymer called ethyl cellulose (EC) to act as a slow-release gel limiting off target toxicity and a speculum-compatible injector to reliably deliver ethanol into the region of interest. Moving forward, the goal of our Academic Industry Partnership (AIP) is to assess the repeatability and depth of EC-ethanol injections administered with the speculum-compatible injector, develop an image-guided injection method for lesion identification, and assess the safety and zone of necrosis caused by EC-ethanol injections in women scheduled for hysterectomy.
