NCT03465618

A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors

Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test if PET scans using 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles, can be used to take pictures of brain tumors. The investigators want to understand how the particles are distributed and removed from the body, which may help others be treated in the future. This will be the first time that 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles are being used in people. The amount of particles given in this study is very small compared to the amount that was used in mice animal studies.

Conditions

• Brain Cancer
• Pituitary Adenoma

Interventions

Type	Name	Description
DRUG	89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging	A low dose spiral CT is performed first per the standard procedure. These images will be used for both attenuation correction and registration of the serial image set. The initial PET brain scan will be acquired up to about 24 hours post injection. Based upon the discretion of the physician, non-surgical patients have the possibility of a second scan and third up to about 48 hours post injection. The times per bed position may be adjusted after the first patient is imaged, and his/her scans evaluated. Additional low dose CT scans will be performed at the image session for attenuation correction and image registration. PET study may be done on a PET-MR scanner for ease.
OTHER	Blood and Urine samples	Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan

Timeline

• Start date: 2018-03-07
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2018-03-14
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study