This phase I pilot trial evaluates the side effects, movement, and absorption of positron-emission tomography (PET) with fluorescent cyclo-(arginine-glycine-aspartate-tyrosine) (cRGDY) polyethylene glycol (PEG)-cyanine 5.5 (Cy5.5) C dots ultrasmall silica particle tracers in imaging patients with malignant brain tumors. A tracer is a radioactive drug that collects in areas of the body that have higher levels of activity. A routine PET scan done with a tracer allows doctors to see how glucose, a type of sugar, is absorbed by brain tumor cells. Diagnostic procedures, such as a PET scan with a radioactive tracer, may help find and diagnose brain tumors and find out how far the cancer may have spread.
Additional locations may be listed on ClinicalTrials.gov for NCT03465618.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Conduct pilot single-dose studies of fluorescent cRGDY PEG-Cy5.5 C dots (89Zr- DFO-cRGDY-PEG-Cy5-C dots) in a limited number of human malignant brain tumor patients to characterize safety, particle tracer penetration, accumulation, intratumoral distribution using PET imaging and/or correlative histology.
SECONDARY OBJECTIVE:
I. In surgical patients, assay particle tracer tissue distributions in tumor tissue specimens using autoradiography.
OUTLINE:
Patients receive fluorescent cRGDY PEG-Cy5.5 C dots ultrasmall silica particle tracers intravenously (IV) and undergo positron emission tomography (PET) scan over 60 minutes 24 hours after the injection. Patients may undergo a second scan 2-4 hours post injection and third scan up to 48 hours post injection at the discretion of the treating physician.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNelson Moss
