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Clinical Development of an Implantable Nanosensor for Early-Stage Ovarian Cancer Detection
Ovarian cancer is the fifth-leading cause of cancer-related deaths among women in the United States and first among gynecologic malignancies. If detected early, however, the survival rate is over 90%. The measurement of ovarian cancer biomarkers has provided only slight benefits because they normally do not appear at detectable levels in the blood until late-stage disease. We believe that a sensor, which can be implanted in the body to detect biomarkers that appear in the vicinity of the ovaries and uterine cavity, could benefit patients at high risk for ovarian cancer or its recurrence. This technology may eventually benefit many cancer patients. In the prior grant periods, we engineered and characterized the first optical nanosensor implant that non-invasively detects an ovarian cancer biomarker, HE4, in patient fluids and in live mouse models of ovarian cancer. This project aims to advance our implantable sensor for the detection of early-stage ovarian cancer to the clinic. We will complete: 1) the design of a clinical device, an IUD-shaped implant, 2) associated preclinical studies, and 3) address any regulatory issues, in order to conduct a clinical trial with this technology. We expect that, at the end of this grant period, we will begin first-in-human trials of this non-invasive biomarker sensor device in ovarian cancer patients.
Many thanks to Douglas A. Levine, MD, of NYU Perlmutter Cancer Center, for his contributions as Co-PI during the first phase of this project.