- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465618
A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors
Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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
|
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.
Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nelson Moss, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pituitary Diseases
- Adenoma
- Pituitary Neoplasms
- Brain Neoplasms
Other Study ID Numbers
- 17-599
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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