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Clinical Trials

Ovarian cancer is known as the 'silent killer' because it is most often diagnosed too late, when it is no longer curable. Worldwide, 230,000 women find out they have the disease, and 140,000 die from it each year.

Effective early detection is key to improving these statistics. Canary Foundation is supporting two ovarian cancer clinical trials that will address both sides of the envisioned cancer screening strategy — blood screening as the first step to detect the presence of a cancer, followed by molecular imaging that will isolate the tumor location. Both trials are being launched by the Pacific Ovarian Cancer Research Consortium (POCRC), a collaborative team of scientists led by Canary team member Dr. Nicole Urban that was awarded a 5-year SPORE grant by the National Cancer Institute.

Present-day diagnosis of ovarian cancer often does not lead to favorable clinical outcomes. Canary Foundation is supporting clinical trials of blood and imaging tests, aiming to create an effective early detection screening program.

Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated Risk Women

Previous clinical trials of ovarian cancer screening programs mostly involved a single biomarker (CA125) as a blood test. This current novel markers trial will incorporate a second blood-based biomarker (HE4) into the screening protocols for clinical decision-making. Furthermore, the trial is testing a new computational algorithm to determine whether the biomarker signals the presence of cancer. The aim of the study is to determine the predictive value for malignant ovarian cancer of a screening program that includes the two blood biomarkers, the new algorithm to decipher a cancer signature from blood biomarkers, and ultrasound as an imaging modality.

The five-year study aims to enroll 1,200 women total, divided into three different risk groups depending on the mutation status of certain cancer risk genes, family history of ovarian cancer, and other factors that may influence a woman's risk of ovarian cancer. All women will undergo blood testing at regular intervals. Women at high risk will be screened semi-annually; the others will be screened annually. This regular screening allows the new algorithm to learn what a woman's own "healthy state" biomarker baseline is, and use it to determine whether the measurement from her most recent doctor visit deviates enough from her baseline to signal the presence of cancer. If this is the case, the woman will be sent to the second step of the screening strategy, which includes ultrasound imaging.

Four clinical sites are participating in this trial: Cedars-Sinai Medical Center in Los Angeles, Stanford University, Swedish Cancer Institute in Seattle, and City of Hope in Duarte, California. Canary Foundation is funding the participation of Stanford University and City of Hope.

For more detailed information about this screening trial, please visit the POCRC website.

Ovarian Cancer Imaging Using Contrast-Enhanced Ultrasound

This clinical trial will investigate a novel molecular imaging technique called contrast-enhanced ultrasound (CEUS) in ovarian cancer patients. Unlike regular ultrasound, targeted ultrasound can enhance signal specifically at tumor sites. The technique makes use of microbubbles, small gas-filled spheres that are injected into the bloodstream to circulate throughout the body. These microbubbles are coated with antibodies that specifically bind to biomarkers found only in tumor vasculature, causing them to adhere within tumor blood vessels, but not within healthy blood vessels. When ultrasound is applied, the microbubbles adhering to the tumor reflect a characteristic sound signature that is distinct from the surrounding tissue and can be used to localize the tumor.

This molecular imaging trial aims to determine safety, feasibility, and dosage requirements for this imaging method in humans. It is scheduled to begin once FDA approval for the microbubbles has been obtained. Canary is proud to provide support for this trial, which will take place at two clinical centers — Swedish Cancer Institute in Seattle and Stanford University.

For more detailed information about this molecular imaging trial, please visit the POCRC website.