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Particle Tracers

89Zr-cRGDY Tracer for Brain Cancer

Phase 1

Waitlist Available

Led By Nelson Moss, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if a new type of PET scan can take pictures of brain tumors. The scan uses 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles, which have only been tested on animals before. The amount of particles given in this study is very small.

Who is the study for?

This trial is for adults over 18 with confirmed malignant brain tumors, pituitary adenomas, or brain metastases from known cancers. Participants must use birth control if of childbearing age and have normal heart function. Pregnant or breastfeeding individuals, those with multiple active cancers, severe claustrophobia, or weight over 400 lbs cannot join.Check my eligibility

What is being tested?

The study tests a new PET scan tracer called 89Zr-DFO-cRGDY-PEG-Cy5-C' dots to see how well it can image brain tumors and track its distribution and removal in the body. This is the first time these particles are used in humans after being tested in mice.See study design

What are the potential side effects?

Since this is the first human test of the tracer, specific side effects are unknown but may include reactions related to PET imaging such as discomfort lying still during scans or allergic reactions to tracers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a confirmed diagnosis of a brain tumor or cancer that has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

distribution within these high-grade gliomas

Trial Design

2Treatment groups

Experimental Treatment

Group I: surgical patientsExperimental Treatment2 Interventions

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.

Group II: non-surgical patientsExperimental Treatment2 Interventions

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,603 Total Patients Enrolled

Nelson Moss, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

106 Total Patients Enrolled

Media Library

Pituitary Adenomas Research Study Groups: non-surgical patients, surgical patients

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals currently being accepted for participation in this experiment?

"Clinicaltrials.gov's records indicate that this medical trial is not actively recruiting patients, as the study was last updated on November 23rd 2022. Nevertheless, there are 479 other clinical trials currently open for enrollment."

Answered by AI

Is there a potential risk to patients undergoing 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging?

"The safety of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging was assessed as a 1 by our Power team, due to this being an initial Phase 1 trial and the limited amount of data available on efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A First in Human Study Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers for Malignant Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03465618.

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