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

NCT03465618 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 17-599
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

89Zr-cRGDY Ultrasmall Silica Particle Tracers; Pet Scan; 17-599

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

surgical patients

EXPERIMENTAL

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.

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

non-surgical patients

EXPERIMENTAL

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

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

Interventions

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

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.

non-surgical patients; surgical patients

Blood and Urine samples OTHER

Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan

non-surgical patients; surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Pituitary Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nelson Moss, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two expert PET scan readers, who are board-certified in Nuclear Medicine, will be designated to read and evaluate PET-CT scans. Volumetric region-of-interest analysis and extraction of the mean and maximum standard uptake values (SUVs) will be provided. Both readers will initially be blinded to the patient's clinical information for scan interpretation. A second interpretation will then be performed after both readers are provided with clinical information about the primary tumor site.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-year microdosing study that will enroll up to 10 surgical or non-surgical patients harboring pituitary adenomas, high grade gliomas or metastatic brain tumors.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: March 7, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)