Brain CancerPhase 1NCT03465618
A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors
A Phase 1 study testing 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging and Blood and Urine samples in people with Brain Cancer and Pituitary Adenoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Pituitary Adenoma
- What is being tested?
- 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging and Blood and Urine samples
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study
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
- Being tested
- 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging, Blood and Urine samples
- Keywords
- 89Zr-cRGDY Ultrasmall Silica Particle Tracers, Pet Scan, 17-599
- Medical subject headings
- Brain Neoplasms, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET ImagingDrug
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.
Blood and Urine samplesOther
Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging; Other: Blood and Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start7 Mar 2018
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson Moss, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465618
- Sponsor's protocol ID
- 17-599
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2018
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study
- ClinicalTrials.gov ID
- NCT03465618
- Acronym / sponsor ID
- 17-599
- Conditions
- Brain Cancer, Pituitary Adenoma
- Keywords
- 89Zr-cRGDY Ultrasmall Silica Particle Tracers, Pet Scan, 17-599
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| surgical patients | Experimental | Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging, Other: Blood and Urine samplesPatients 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. |
| non-surgical patients | Experimental | Drug: 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging, Other: Blood and Urine samplesBefore 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET ImagingA 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. | Drug | non-surgical patients, surgical patients |
| Blood and Urine samplesVenous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan | Other | non-surgical patients, surgical patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Brain Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
RecruitingObservational study
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Sarcoma, Giant Cell Tumor of Bone
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Moss, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging and Blood and Urine samples in people with Brain Cancer and Pituitary Adenoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distribution within these high-grade gliomas (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.