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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Pituitary Adenoma; Brain Cancer

Treatments: Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging; Other: Blood and Urine samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03465618

17-599

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

surgical patients

Experimental group

Description:

Patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. The patient's PET/CT Brain scans may be acquired prior to surgery. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging.

Treatment:

Other: Blood and Urine samples

Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging

non-surgical patients

Experimental group

Description:

Before the patient's PET Brain scans patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging

Treatment:

Other: Blood and Urine samples

Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging