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

STATUS

Recruiting
days left to enroll

45
participants needed

16
sponsor

Memorial Sloan Kettering Cancer Center

Updated on 4 October 2022

See if I qualify

cancer

primary brain tumors

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.

Details

Condition	Brain Cancer, Pituitary Adenoma
Treatment	blood and urine samples, 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET/CT Imaging, 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging
Clinical Study Identifier	NCT03465618
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	years of age or older
	Histologically confirmed diagnosis of malignant primary brain tumor clinical and radiographic findings consistent with a pituitary adenoma, or known metastatic cancer with brain lesion presumed to be metastatic
	Normal baseline cardiac function based upon pre-operative evaluation at the physcian's discretion
	All patients of childbearing age must use an acceptable form of birth control
	Women who are pre-menopausal must have a negative serum pregnancy test
Exclusion Criteria
	Known pregnancy or breast-feeding Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the tracer
	°This includes patients with uncontrolled infection, chronic renal
	insufficiency, myocardial infarction within the past 6 months, unstable
	angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic
	active or persistent hepatitis, or New York Heart Association Classification
	III or IV heart disease
	More than one metastatic cancer active in the last 5 years
	Active metastatic cancer in addition to malignant primary brain tumor
	Weight greater than the 400-lb weight limit of the PET scanner
	Unmanageable claustrophobia
	Inability to lie in the scanner for 30 minutes

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