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

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Childhood Medulloblastoma; Recurrent Childhood Ependymoma; Untreated Childhood Brain Stem Glioma; Untreated Childhood Medulloblastoma; Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor; Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Diffuse Astrocytoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Myxopapillary Ependymoma; Adult Oligodendroglioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymoma; Untreated Childhood Anaplastic Astrocytoma; Untreated Childhood Anaplastic Oligodendroglioma; Untreated Childhood Giant Cell Glioblastoma; Untreated Childhood Glioblastoma; Untreated Childhood Gliomatosis Cerebri; Untreated Childhood Gliosarcoma; Untreated Childhood Oligodendroglioma; Recurrent Adult Brain Tumor; Adult Brain Stem Glioma; Adult Subependymal Giant Cell Astrocytoma; Acoustic Schwannoma; Adult Anaplastic Meningioma; Adult Choroid Plexus Tumor; Adult Craniopharyngioma; Adult Ependymoblastoma; Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Medulloblastoma; Adult Meningeal Hemangiopericytoma; Adult Papillary Meningioma; Adult Pineoblastoma; Adult Pineocytoma; 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 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 Fibrillary Astrocytoma; Recurrent Childhood Gemistocytic Astrocytoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliomatosis Cerebri; Recurrent Childhood Gliosarcoma; 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 Cerebellar Astrocytoma; Untreated Childhood Cerebral Astrocytoma; Untreated Childhood Diffuse Astrocytoma; Untreated Childhood Fibrillary Astrocytoma; Untreated Childhood Gemistocytic Astrocytoma; Untreated Childhood Oligoastrocytoma; 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 Visual Pathway and Hypothalamic Glioma; Untreated Childhood Visual Pathway Glioma
• Intervention / Treatment: Other: laboratory biomarker analysis; Radiation: gallium Ga 68-edotreotide; Procedure: positron emission tomography; Procedure: computed tomography

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

Other: laboratory biomarker analysis; Correlative studies; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy		Up to 30 days

Collaborators and Investigators

• Sponsor: Sue O'Dorisio
• Collaborators: National Cancer Institute (NCI); Ride for Kids

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Eye Diseases; Disease Attributes; Musculoskeletal Diseases; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Bone Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neuroendocrine Tumors; Sarcoma; Neoplasms, Vascular Tissue; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Meningeal Neoplasms; Cranial Nerve Neoplasms; Bone Neoplasms; Neoplasms, Fibrous Tissue; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Optic Nerve Neoplasms; Cerebral Ventricle Neoplasms; Neoplasms; Glioblastoma; Recurrence; Glioma; Brain Neoplasms; Sarcoma, Ewing; Ependymoma; Medulloblastoma; Astrocytoma; Gliosarcoma; Oligodendroglioma; Meningioma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neurilemmoma; Neuroma, Acoustic; Glioma, Subependymal; Pinealoma; Neoplasms, Neuroepithelial; Hemangiopericytoma; Solitary Fibrous Tumors; Optic Nerve Glioma; Craniopharyngioma; Adamantinoma; Choroid Plexus Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Radiopharmaceuticals; Octreotide; Edotreotide
• Other Study ID Numbers: 201302711; P30CA086862 (U.S. NIH Grant/Contract)