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

Adult Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02194452
• Other study ID #: 201302711
• Secondary ID: P30CA086862
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2014
• Last updated: April 27, 2017
• Start date: September 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• 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)
• Astrocytoma
• Brain Neoplasms
• 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
• Choroid Plexus Neoplasms
• Craniopharyngioma
• Ependymoma
• Glioblastoma
• Glioma
• Gliosarcoma
• Hemangiopericytoma
• Medulloblastoma
• Meningeal Melanocytoma
• Meningioma
• Neoplasms
• Neoplasms, Neuroepithelial
• Neurilemmoma
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Neuroma, Acoustic
• Newly Diagnosed Childhood Ependymoma
• Oligodendroglioma
• Optic Nerve Glioma
• Pinealoma
• 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

Intervention

Radiation:
• gallium Ga 68-edotreotide
Undergo gallium Ga 68-edotreotide PET/CT

Procedure:
• positron emission tomography
Undergo gallium Ga 68-edotreotide PET/CT
• computed tomography
Undergo gallium Ga 68-edotreotide PET/CT

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Sue O'Dorisio	National Cancer Institute (NCI), Ride for Kids

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide	The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).	Baseline up to 30 days
Primary	Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy		Up to 30 days