Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-03-31

Brief Summary

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This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.

II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.

OUTLINE:

Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.

Conditions

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Acoustic Schwannoma Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Meningioma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Choroid Plexus Tumor Adult Craniopharyngioma Adult Diffuse Astrocytoma Adult Ependymoblastoma Adult Ependymoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Grade I Meningioma Adult Grade II Meningioma Adult Medulloblastoma Adult Meningeal Hemangiopericytoma Adult Mixed Glioma Adult Myxopapillary Ependymoma Adult Oligodendroglioma Adult Papillary Meningioma Adult Pilocytic Astrocytoma Adult Pineal Gland Astrocytoma Adult Pineoblastoma Adult Pineocytoma Adult Subependymal Giant Cell Astrocytoma Adult Subependymoma Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) Childhood Choroid Plexus Tumor Childhood Craniopharyngioma Childhood Ependymoblastoma Childhood Grade I Meningioma Childhood Grade II Meningioma Childhood Grade III Meningioma Childhood High-grade Cerebellar Astrocytoma Childhood High-grade Cerebral Astrocytoma Childhood Infratentorial Ependymoma Childhood Low-grade Cerebellar Astrocytoma Childhood Low-grade Cerebral Astrocytoma Childhood Medulloepithelioma Childhood Supratentorial Ependymoma Meningeal Melanocytoma Newly Diagnosed Childhood Ependymoma Recurrent Adult Brain Tumor Recurrent Childhood Anaplastic Astrocytoma Recurrent Childhood Anaplastic Oligoastrocytoma Recurrent Childhood Anaplastic Oligodendroglioma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Diffuse Astrocytoma Recurrent Childhood Ependymoma Recurrent Childhood Fibrillary Astrocytoma Recurrent Childhood Gemistocytic Astrocytoma Recurrent Childhood Giant Cell Glioblastoma Recurrent Childhood Glioblastoma Recurrent Childhood Gliomatosis Cerebri Recurrent Childhood Gliosarcoma Recurrent Childhood Medulloblastoma Recurrent Childhood Oligoastrocytoma Recurrent Childhood Oligodendroglioma Recurrent Childhood Pilocytic Astrocytoma Recurrent Childhood Pilomyxoid Astrocytoma Recurrent Childhood Pineoblastoma Recurrent Childhood Pleomorphic Xanthoastrocytoma Recurrent Childhood Protoplasmic Astrocytoma Recurrent Childhood Subependymal Giant Cell Astrocytoma Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor Recurrent Childhood Visual Pathway and Hypothalamic Glioma Recurrent Childhood Visual Pathway Glioma Untreated Childhood Anaplastic Astrocytoma Untreated Childhood Anaplastic Oligodendroglioma Untreated Childhood Brain Stem Glioma Untreated Childhood Cerebellar Astrocytoma Untreated Childhood Cerebral Astrocytoma Untreated Childhood Diffuse Astrocytoma Untreated Childhood Fibrillary Astrocytoma Untreated Childhood Gemistocytic Astrocytoma Untreated Childhood Giant Cell Glioblastoma Untreated Childhood Glioblastoma Untreated Childhood Gliomatosis Cerebri Untreated Childhood Gliosarcoma Untreated Childhood Medulloblastoma Untreated Childhood Oligoastrocytoma Untreated Childhood Oligodendroglioma Untreated Childhood Pilocytic Astrocytoma Untreated Childhood Pilomyxoid Astrocytoma Untreated Childhood Pineoblastoma Untreated Childhood Pleomorphic Xanthoastrocytoma Untreated Childhood Protoplasmic Astrocytoma Untreated Childhood Subependymal Giant Cell Astrocytoma Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor Untreated Childhood Visual Pathway and Hypothalamic Glioma Untreated Childhood Visual Pathway Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (gallium Ga 68-edotreotide PET/CT)

Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.

Interventions: gallium Ga 68-edotreotide, positron emission tomography, computed tomography, laboratory biomarker analysis

Group Type EXPERIMENTAL

gallium Ga 68-edotreotide

Intervention Type RADIATION

Undergo gallium Ga 68-edotreotide PET/CT

positron emission tomography

Intervention Type PROCEDURE

Undergo gallium Ga 68-edotreotide PET/CT

computed tomography

Intervention Type PROCEDURE

Undergo gallium Ga 68-edotreotide PET/CT

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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gallium Ga 68-edotreotide

Undergo gallium Ga 68-edotreotide PET/CT

Intervention Type RADIATION

positron emission tomography

Undergo gallium Ga 68-edotreotide PET/CT

Intervention Type PROCEDURE

computed tomography

Undergo gallium Ga 68-edotreotide PET/CT

Intervention Type PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC FDG-PET, PET, PET scan, tomography, emission computed tomography, computed

Eligibility Criteria

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Inclusion Criteria

* Patients presenting with brain tumors will be eligible for this study
* Eligible subjects must be able and willing to undergo the procedures of the study
* Electronic version of pre-surgery MRI must be available for co-registration purposes
* Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin of body that would preclude obtaining an MRI as part of the initial study evaluation
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons
* Presence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance

Minimum Eligible Age

6 Months

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No