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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465618
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Brain Cancer Pituitary Adenoma Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging Other: Blood and Urine samples Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: surgical patients
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
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

Experimental: non-surgical patients
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
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




Primary Outcome Measures :
  1. distribution within these high-grade gliomas [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465618


Contacts
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Contact: Nelson Moss, MD 212-639-7075 mossn@mskcc.org
Contact: Heiko Schöder, MD 212-639-2079

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nelson Moss, MD    212-639-7075      
Contact: Heiko Schöder, MD    212-639-2079      
Principal Investigator: Nelson Moss, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Nelson Moss, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03465618    
Other Study ID Numbers: 17-599
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
89Zr-cRGDY Ultrasmall Silica Particle Tracers
Pet Scan
17-599
Additional relevant MeSH terms:
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Brain Neoplasms
Adenoma
Pituitary Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pituitary Diseases
Hypothalamic Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms