Clinical trial NCT02194452: Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Official title: Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Ride for Kids
First posted: 2014-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide
timeFrame: Baseline up to 30 days
measure: Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: M. Sue O'Dorisio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: