Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 1

Conditions: Meningioma

Treatments: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Radiation: Gallium Ga 68-DOTATATE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03953131

2018-0659 (Other Identifier)

NCI-2019-00214 (Registry Identifier)

Details and patient eligibility

About

This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas.

Full description

PRIMARY OBJECTIVES:

I. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT).

II. To assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (SUV) of the tumor compared to background brain parenchyma.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV) over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any meningioma with at least 10 mm measurable residual disease.
• Age 18 years or older.
• Planned radiation therapy for meningioma.
• Ability to understand and the willingness to sign a IRB approved written informed consent document in accordance with regulatory and institutional guidelines before study entry.
• No restriction based on language that would prohibit enrollment of the participant. IRB approved VTPS form will be utilized when non-English Speaking patient is enrolled

Exclusion criteria

• Neurofibromatosis type 1 or 2.
• Children.
• Pregnant.
• Contraindication to MR imaging.
• Body weight greater than 400 lbs (181.4kg).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Diagnostic (gallium Ga 68-DOTATATE PET/CT)

Experimental group

Description:

Patients receive gallium Ga 68-DOTATATE IV over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.

Treatment:

Radiation: Gallium Ga 68-DOTATATE

Procedure: Computed Tomography

Procedure: Positron Emission Tomography