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 : February 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningioma | Procedure: Computed Tomography Radiation: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography | Phase 1 |
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 |
Estimated Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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, 2022 |
Estimated Study Completion Date : | September 1, 2022 |

Arm | Intervention/treatment |
---|---|
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.
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Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Radiation: Gallium Ga 68-DOTATATE Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo PET/CT
Other Names:
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any meningioma with at least 10 mm measurable residual disease
- Planned radiation therapy for meningioma
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Neurofibromatosis type 1 or 2
- Pregnant
- Contraindication to magnetic resonance (MR) imaging
- Body weight greater than 400 pounds (lbs) (181.4kg)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953131
Contact: Jason M Johnson | 713-792-8443 | jjohnson12@mdanderson.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 |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT03953131 |
Other Study ID Numbers: |
2018-0659 NCI-2019-00214 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0659 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
First Posted: | May 16, 2019 Key Record Dates |
Last Update Posted: | February 13, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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