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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03465618
• Other study ID #: 17-599
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 7, 2018
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Related Conditions & MeSH terms

• Adenoma
• Brain Cancer
• Brain Neoplasms
• Pituitary Adenoma
• Pituitary Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distribution within these high-grade gliomas	using serial PET imaging and/or correlative histologyFollowing tumor biopsy or surgical resection, histologic assessments will be performed using autoradiography to visualize the distribution of this agent within tumor tissue specimens.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center