- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03953131
Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jason M Johnson
- Phone Number: 713-792-8443
- Email: jjohnson12@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
Metabolic response to radiation therapy
Time Frame: Up to 1 year
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Meningioma
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Other Study ID Numbers
- 2018-0659 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-00214 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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