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

M.D. Anderson Cancer Center13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Meningioma

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Gallium Ga 68-DOTATATERADIATION

Given IV

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Imaging with Gallium Ga 68-DOTATATE

Lesions will be defined based on areas of T1 post contrast enhancement as assessed by magnetic resonance imaging (MRI). The largest bidimension measurements of the lesion on post-contrast T1 weighted magnetic resonance (MR) imaging will be recorded. Regions of interest (ROI) analysis of these regions of abnormal enhancement will be used to assess the max standard uptake values (SUV) of the lesion (tumor) as well as adjacent normal appearing brain parenchyma (background). These calculations will be repeated on the post-treatment scan as well as calculations for tumor to background (T/B) ratios.

Time frame: Up to 1 year

Metabolic response to radiation therapy

Will be measured by a reduction in the tumor to background ratio of the maximum SUV of the tumor compared to background brain parenchyma.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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