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

Sue O'Dorisio

Status: Withdrawn

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

Treatments: Procedure: positron emission tomography; Other: laboratory biomarker analysis; Radiation: gallium Ga 68-edotreotide; Procedure: computed tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02194452

201302711

P30CA086862 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 6 months to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (gallium Ga 68-edotreotide PET/CT)

Experimental group

Description:

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

Treatment:

Procedure: computed tomography

Other: laboratory biomarker analysis

Radiation: gallium Ga 68-edotreotide

Procedure: positron emission tomography