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

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ClinicalTrials.gov Identifier: NCT02194452
Recruitment Status : Withdrawn
First Posted : July 18, 2014
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Ride for Kids
Information provided by (Responsible Party):
Sue O'Dorisio, University of Iowa

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 Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : September 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


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

Procedure: positron emission tomography
Undergo gallium Ga 68-edotreotide PET/CT
Other Name: FDG-PET, PET, PET scan, tomography, emission computed

Procedure: computed tomography
Undergo gallium Ga 68-edotreotide PET/CT
Other Name: tomography, computed

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide [ Time Frame: 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 -).

  2. Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy [ Time Frame: Up to 30 days ]


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Ages Eligible for Study:   6 Months to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194452


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Sue O'Dorisio
National Cancer Institute (NCI)
Ride for Kids
Investigators
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Principal Investigator: M. Sue O'Dorisio, MD, PhD University of Iowa

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Responsible Party: Sue O'Dorisio, Professor Pediatrics-HEM-Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT02194452     History of Changes
Other Study ID Numbers: 201302711
P30CA086862 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Neoplasms
Glioblastoma
Glioma
Brain Neoplasms
Astrocytoma
Ependymoma
Gliosarcoma
Meningioma
Oligodendroglioma
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neurilemmoma
Craniopharyngioma
Adamantinoma
Choroid Plexus Neoplasms
Pinealoma
Optic Nerve Glioma
Hemangiopericytoma
Glioma, Subependymal
Neoplasms, Neuroepithelial
Neuroma, Acoustic
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases