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

Meningioma Clinical Trial

Official title:

A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953131
• Other study ID #: 2018-0659
• Secondary ID: NCI-2019-0021420
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Meningioma

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT

Radiation:
• Gallium Ga 68-DOTATATE
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year
Primary	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.	Up to 1 year

External Links

•   MD Anderson Cancer Center