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

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

NCT02194452•Sue O'Dorisio

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

0 - 29 years

Sex

ALL

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

Locations (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

April 28, 2017

Conditions

Acoustic SchwannomaAdult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic MeningiomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Choroid Plexus TumorAdult CraniopharyngiomaAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Grade I MeningiomaAdult Grade II MeningiomaAdult MedulloblastomaAdult Meningeal HemangiopericytomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Papillary MeningiomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult PineoblastomaAdult PineocytomaAdult Subependymal Giant Cell AstrocytomaAdult SubependymomaAdult Supratentorial Primitive Neuroectodermal Tumor (PNET)Childhood Choroid Plexus TumorChildhood CraniopharyngiomaChildhood EpendymoblastomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral AstrocytomaChildhood Infratentorial EpendymomaChildhood Low-grade Cerebellar AstrocytomaChildhood Low-grade Cerebral AstrocytomaChildhood MedulloepitheliomaChildhood Supratentorial EpendymomaMeningeal MelanocytomaNewly Diagnosed Childhood EpendymomaRecurrent Adult Brain TumorRecurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood Diffuse AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Fibrillary AstrocytomaRecurrent Childhood Gemistocytic AstrocytomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood GliosarcomaRecurrent Childhood MedulloblastomaRecurrent Childhood OligoastrocytomaRecurrent Childhood OligodendrogliomaRecurrent Childhood Pilocytic AstrocytomaRecurrent Childhood Pilomyxoid AstrocytomaRecurrent Childhood PineoblastomaRecurrent Childhood Pleomorphic XanthoastrocytomaRecurrent Childhood Protoplasmic AstrocytomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaUntreated Childhood Anaplastic AstrocytomaUntreated Childhood Anaplastic OligodendrogliomaUntreated Childhood Brain Stem GliomaUntreated Childhood Cerebellar AstrocytomaUntreated Childhood Cerebral AstrocytomaUntreated Childhood Diffuse AstrocytomaUntreated Childhood Fibrillary AstrocytomaUntreated Childhood Gemistocytic AstrocytomaUntreated Childhood Giant Cell GlioblastomaUntreated Childhood GlioblastomaUntreated Childhood Gliomatosis CerebriUntreated Childhood GliosarcomaUntreated Childhood MedulloblastomaUntreated Childhood OligoastrocytomaUntreated Childhood OligodendrogliomaUntreated Childhood Pilocytic AstrocytomaUntreated Childhood Pilomyxoid AstrocytomaUntreated Childhood PineoblastomaUntreated Childhood Pleomorphic XanthoastrocytomaUntreated Childhood Protoplasmic AstrocytomaUntreated Childhood Subependymal Giant Cell AstrocytomaUntreated Childhood Supratentorial Primitive Neuroectodermal TumorUntreated Childhood Visual Pathway and Hypothalamic GliomaUntreated Childhood Visual Pathway Glioma

Interventions

gallium Ga 68-edotreotide

RADIATION

positron emission tomography

PROCEDURE

computed tomography

PROCEDURE

laboratory biomarker analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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