NCT03953131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

4.6 years

First QC Date

February 1, 2019

Last Update Submit

August 30, 2023

Conditions

Meningioma

Outcome Measures

Primary Outcomes (2)

  • Imaging with Gallium Ga 68-DOTATATE

    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

    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

Study Arms (1)

Diagnostic (gallium Ga 68-DOTATATE PET/CT)

EXPERIMENTAL

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 TomographyRadiation: Gallium Ga 68-DOTATATEProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic (gallium Ga 68-DOTATATE PET/CT)
Gallium Ga 68-DOTATATERADIATION

Given IV

Also known as: (68)Ga-DOTA-TATE, 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Diagnostic (gallium Ga 68-DOTATATE PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (gallium Ga 68-DOTATATE PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurofibromatosis type 1 or 2.
  • Children.
  • Pregnant.
  • Contraindication to MR imaging.
  • Body weight greater than 400 lbs (181.4kg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Meningioma

Interventions

Ga(III)-DOTATOCgallium Ga 68 dotatateMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jason M Johnson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

May 16, 2019

Study Start

January 10, 2019

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)