Clinical Trials

Lung cancer is the world's top cancer killer, with over 40% of cases diagnosed at an advanced stage when the cancer has already spread widely beyond the lung and survival outcomes are extremely poor. Toward the goal of accurate earlier detection of lung cancer, Canary Foundation is supporting the development of molecular imaging agents that can detect small tumors earlier in disease, allowing for non-invasive detection and improved characterization of smaller lung nodules. We move our most promising molecular imaging agents into safety and efficacy studies in preparation for FDA-approved Investigational New Drug (IND) clinical trials.

Clinical trials are being conducted by the Stanford Nuclear Medicine Clinic of Stanford University Medical School's Department of Radiology, under the leadership of Dr. Sanjiv (Sam) Gambhir. Dr. Gambhir's group developed the novel imaging agent [¹⁸F] FPPRGD2, which targets an integrin receptor (a molecule on cell surfaces) called alpha v beta 3 (α_vβ₃) integrin. Integrins on tumor cells and new blood vessels are hallmarks of new tumor formation, so they are potential targets for early cancer detection.

(Left) Chemical structure of the novel imaging agent [¹⁸F] FPPRGD2. (Right) Picture taken 1 hour after the administration of [¹⁸F] FPPRGD2 in a healthy human volunteer followed by combined positron emission tomography and computed tomography (PET/CT) imaging.

Through an exploratory IND (Investigational New Drug) application approved by the FDA, the Stanford Nuclear Medicine group is now testing this imaging agent in patients for the first time. The study has collected data on the first healthy volunteers imaged with this imaging agent (see above). The low background signal in the thorax using this imaging agent should allow for high tumor-to-background contrast ratio in the lungs, making it promising for molecular imaging of lung cancer. The Stanford group is now in the process of expanding this clinical trial to include imaging lung cancer patients and will report on progress in the coming months.

For more information about Stanford Nuclear Medicine, see the group's Stanford University website.