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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03953131
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
1
Location
1
Arm
43.7
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Computed Tomography
  • Radiation: Gallium Ga 68-DOTATATE
  • Procedure: Positron Emission Tomography
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT).

  2. 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

Study Type:
Interventional
Anticipated 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 :
Jan 10, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

    Primary Outcome Measures

    1. Imaging with Gallium Ga 68-DOTATATE [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03953131
    Other Study ID Numbers:
    • 2018-0659
    • NCI-2019-00214
    • 2018-0659
    • P30CA016672
    First Posted:
    May 16, 2019
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Meningioma
    1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

    Study Results

    No Results Posted as of Feb 13, 2020