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Trial record 1 of 2 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | meningioma | United States | First posted from 04/01/2019 to 07/31/2019
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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meningioma Procedure: Computed Tomography Radiation: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography Phase 1

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Radiation: Gallium Ga 68-DOTATATE
Given IV
Other Names:
  • (68)Ga-DOTA-TATE
  • 68Ga-DOTATATE
  • Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jason M Johnson 713-792-8443 jjohnson12@mdanderson.org

Locations
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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         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action