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

Phase 1

Completed

• Conditions: Meningioma
• Interventions: Procedure: Computed Tomography; Radiation: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography

• Registration Number: NCT03953131
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Status Verified: 2023-08
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (gallium Ga 68-DOTATATE PET/CT)	Gallium Ga 68-DOTATATE	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.
Diagnostic (gallium Ga 68-DOTATATE PET/CT)	Positron Emission Tomography	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.
Diagnostic (gallium Ga 68-DOTATATE PET/CT)	Computed Tomography	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.

Primary Outcome Measures

Name	Time	Method
Imaging with Gallium Ga 68-DOTATATE	Up to 1 year	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.
Metabolic response to radiation therapy	Up to 1 year	Will be measured by a reduction in the tumor to background ratio of the maximum SUV of the tumor compared to background brain parenchyma.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States