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
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 IdentifierNCT03465618
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

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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