Clinical Trials

First-in-Human Trial in Metastatic Melanoma Patients Using an FDA IND-Approved (IND#110375) Multimodal 124I-Labeled cRGDY Silica Nanomolecular Particle Tracer

Schematic of the 124I-cRGDY-PEGylated core-shell silica nanoparticleSchematic of the 124I-cRGDY-PEGylated core-shell silica nanoparticle with surface-bearing radiolabels and peptides and core-containing reactive-dye molecules (insets).

We are evaluating a novel, tumor-selective silica nanoparticle tracer (124I-cyclic Arg-Gly-Asp-Tyr (cRGDY)-PEG-dots or 124I-cRGDY-PEG-dots) to determine whether this probe has desirable in vivo characteristics as a PET radiotracer, including efficient renal clearance, low background signal, stability, and biosafety, in humans. It is the first inorganic particle of its class to be approved as a “drug” for clinical use.  

Multicenter Trial Investigating Sodium Magnetic Resonance Imaging (MRI) for Monitoring Brain Tumor Response to Radiation

As part of a multicenter clinical trial with the University of Illinois at Chicago, we are using sodium MRI in high-grade glioma patients to serially monitor tissue viability, in the form of tissue sodium concentrations, during radiation therapy. A goal of the study is to evaluate whether sodium MRI is sensitive to tumor response on a time scale that could inform decision making about radiation therapy during treatment.

Image-Guided Stereotactic Biopsy of High-Grade Gliomas

We are investigating potential links between MRI-PET imaging findings at sites of regional heterogeneity within high-grade gliomas and correlative tissue markers and/or expression profiles derived from tissue biopsy specimens.