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

Sponsor

Sue O'Dorisio (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02194452

Collaborator

National Cancer Institute (NCI) (NIH), Ride for Kids (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: gallium Ga 68-edotreotide Procedure: positron emission tomography Procedure: computed tomography Other: laboratory biomarker analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Radiation: gallium Ga 68-edotreotide Undergo gallium Ga 68-edotreotide PET/CT Other Names: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC Procedure: positron emission tomography Undergo gallium Ga 68-edotreotide PET/CT Other Names: FDG-PET, PET, PET scan, tomography, emission computed Procedure: computed tomography Undergo gallium Ga 68-edotreotide PET/CT Other Names: tomography, computed Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

Experimental: 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

Radiation: gallium Ga 68-edotreotide

Undergo gallium Ga 68-edotreotide PET/CT

Other Names:

Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC

Procedure: positron emission tomography

Undergo gallium Ga 68-edotreotide PET/CT

Other Names:

FDG-PET, PET, PET scan, tomography, emission computed

Procedure: computed tomography

Undergo gallium Ga 68-edotreotide PET/CT

Other Names:

tomography, computed

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide [Baseline up to 30 days]
The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy [Up to 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 29 Years

Sexes Eligible for Study:

All

Accepts 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