What is the mechanism of action of this treatment?

The most common treatments for meningioma include surgical resection, radiation therapy, and radiolabeled somatostatin analogs. Radiolabeled somatostatin analogs, such as Ga-68-DOTATATE and Ga-68-DOTATOC, work by binding to somatostatin receptors, which are often overexpressed on meningioma cells. This binding allows for precise PET imaging, enabling better localization and characterization of the tumor. This is crucial for meningioma patients as it aids in accurate diagnosis, treatment planning, and monitoring of disease progression, ultimately improving clinical outcomes.

What side effects are associated with this type of intervention?

The known side effects of treatments for meningioma using radiolabeled somatostatin analogs like Ga-68-DOTATATE and Ga-68-DOTATOC include nausea, hematologic toxicities (such as thrombocytopenia, lymphopenia, anemia, and leukopenia), and nephrotoxicity. These side effects are typically mild but can be severe in some cases, especially in patients with pre-existing conditions or those who have undergone extensive prior treatments.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved radiolabeled somatostatin analogs like Ga-68-DOTATATE and Ga-68-DOTATOC for the treatment of meningioma. These agents are primarily used for PET imaging to detect somatostatin receptor-positive tumors, including neuroendocrine tumors. For meningioma, treatment typically involves surgery, radiation therapy, and in some cases, chemotherapy. Clinical trials are ongoing to explore the efficacy of these imaging agents in meningioma management.

What other types of research exist?

Promising novel alternatives to Ga-68-DOTATATE and Ga-68-DOTATOC for PET imaging in meningioma patients may include radiopharmaceuticals like 18F-fluciclovine and 68Ga-PSMA-11, which have shown efficacy in other types of tumors. Additionally, advancements in molecularly targeted therapies and the development of new radiotracers targeting specific tumor markers could provide new options for imaging and treatment.

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Radiopharmaceutical

Ga-68-DOTATATE vs. Ga-68-DOTATOC PET Scans for Meningioma

Phase 2

Waitlist Available

Led By Jana Ivanidze, MD/Ph.D

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

No contraindications to either radiotracer

Be older than 18 years old

Must not have

Age less than 18 years

Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is evaluating different imaging scans to determine which one is more effective in detecting brain tumors in patients with meningioma. The scans use substances that make the tumors more visible, aiding doctors in their diagnosis.

Who is the study for?

This trial is for adults who are suspected to have meningioma and are preparing for surgery. They must be able to lie still on a scanner table and not have any reasons they can't receive the radiotracers being tested.

What is being tested?

The study aims to directly compare two imaging agents, Ga-68-DOTATATE and Ga-68-DOTATOC, using PET/CT or PET/MR scans in patients with meningioma to see which provides better information.

What are the potential side effects?

While the document doesn't list specific side effects, similar diagnostic agents may cause mild irritation at the injection site, nausea, or allergic reactions. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have no known allergies or reactions to diagnostic dyes or tracers.

Exclusion Criteria

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

Select...

I am under 18 years old.

Select...

I cannot lay on a scanner table for long due to pain or claustrophobia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.

Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.

Secondary study objectives

Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.

Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.

Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with MeningiomaExperimental Treatment2 Interventions

Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

0 / 3Eligibility 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

The most common treatments for meningioma include surgical resection, radiation therapy, and radiolabeled somatostatin analogs. Radiolabeled somatostatin analogs, such as Ga-68-DOTATATE and Ga-68-DOTATOC, work by binding to somatostatin receptors, which are often overexpressed on meningioma cells. This binding allows for precise PET imaging, enabling better localization and characterization of the tumor. This is crucial for meningioma patients as it aids in accurate diagnosis, treatment planning, and monitoring of disease progression, ultimately improving clinical outcomes.