What is the mechanism of action of this treatment?

Common treatments for pituitary adenomas include surgical resection, medical therapy, and radiation therapy. Surgical resection aims to physically remove the tumor, often using minimally invasive techniques. Medical therapy, such as dopamine agonists (e.g., cabergoline) or somatostatin analogs (e.g., octreotide), works by inhibiting hormone secretion and reducing tumor size. Radiation therapy targets and destroys tumor cells using high-energy radiation. Enhanced imaging techniques, like the use of 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles in PET scans, are crucial as they provide detailed visualization of the tumor, aiding in precise diagnosis, treatment planning, and monitoring of therapeutic efficacy. This is particularly important for pituitary adenomas, where accurate localization and assessment of the tumor can significantly impact treatment outcomes and patient quality of life.

What side effects are associated with this type of intervention?

Common treatments for pituitary adenomas include surgery, radiation therapy, and medical therapy. Surgery can lead to complications such as cerebrospinal fluid leaks, infection, and damage to surrounding brain structures. Radiation therapy may cause fatigue, hair loss at the treatment site, and long-term hormonal deficiencies. Medical therapy, which often involves dopamine agonists or somatostatin analogs, can result in side effects like nausea, headaches, and gastrointestinal disturbances. Imaging agents used in PET scans, such as the 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles, are generally well-tolerated but may cause mild reactions like injection site pain or allergic responses in rare cases.

What prior FDA approvals exist?

FDA-approved treatments for pituitary adenomas primarily include medications such as dopamine agonists (e.g., cabergoline, bromocriptine) for prolactinomas, somatostatin analogs (e.g., octreotide, lanreotide) for growth hormone-secreting tumors, and hormone replacement therapies. Surgical resection and radiation therapy are also common treatments. While there are no specific FDA-approved imaging agents for pituitary adenomas similar to the 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles used in PET scans for brain tumors, advancements in imaging techniques continue to evolve, enhancing the detection and management of these tumors.

What other types of research exist?

Promising novel alternatives for enhanced imaging of pituitary adenomas via PET scans include [68Ga]-DOTATOC, [55Co]Co-DOTATATE, and [18F]-SiFAlin-TATE. These agents have demonstrated superior image contrast and high binding affinities to somatostatin receptor-positive tumors, which are relevant for pituitary adenomas.

← Back to Search

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

Must not have

Active metastatic cancer in addition to malignant primary brain tumor

More than one metastatic cancer active in the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of PET scan that uses tiny particles to take clearer pictures of brain tumors. The study aims to see how these particles spread and leave the body. This could help improve future treatments for brain tumor patients.

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.

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.

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

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have cancer that has spread from my brain to other parts of my body.

Select...

I have had more than one cancer spread in the last 5 years.

Select...

I cannot stay still in a scanner for 30 minutes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

distribution within these high-grade gliomas

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pituitary adenomas include surgical resection, medical therapy, and radiation therapy. Surgical resection aims to physically remove the tumor, often using minimally invasive techniques. Medical therapy, such as dopamine agonists (e.g., cabergoline) or somatostatin analogs (e.g., octreotide), works by inhibiting hormone secretion and reducing tumor size. Radiation therapy targets and destroys tumor cells using high-energy radiation. Enhanced imaging techniques, like the use of 89Zr-DFO-cRGDY-PEG-Cy5-C' dot particles in PET scans, are crucial as they provide detailed visualization of the tumor, aiding in precise diagnosis, treatment planning, and monitoring of therapeutic efficacy. This is particularly important for pituitary adenomas, where accurate localization and assessment of the tumor can significantly impact treatment outcomes and patient quality of life.