Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
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|ClinicalTrials.gov Identifier: NCT03953131|
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Meningioma||Procedure: Computed Tomography Radiation: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography||Phase 1|
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.
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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: Diagnostic (gallium Ga 68-DOTATATE PET/CT)
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.
Procedure: Computed Tomography
Radiation: Gallium Ga 68-DOTATATE
Procedure: Positron Emission Tomography
- Ability of imaging with Gallium Ga 68-DOTATATE [ Time Frame: 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.
- Ability to assess metabolic response to radiation therapy [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953131
|Contact: Jason M Johnsonfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jason M. Johnson 713-792-8443|
|Principal Investigator: Jason M. Johnson|
|Principal Investigator:||Jason M Johnson||M.D. Anderson Cancer Center|