Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Primary Purpose
Acoustic Schwannoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gallium Ga 68-edotreotide
positron emission tomography
computed tomography
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Acoustic Schwannoma
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
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (gallium Ga 68-edotreotide PET/CT)
Arm Description
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
Outcomes
Primary Outcome Measures
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 -).
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
Secondary Outcome Measures
Full Information
NCT ID
NCT02194452
First Posted
July 16, 2014
Last Updated
April 27, 2017
Sponsor
Sue O'Dorisio
Collaborators
National Cancer Institute (NCI), Ride for Kids
1. Study Identification
Unique Protocol Identification Number
NCT02194452
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sue O'Dorisio
Collaborators
National Cancer Institute (NCI), Ride for Kids
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (gallium Ga 68-edotreotide PET/CT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
gallium Ga 68-edotreotide
Other Intervention Name(s)
Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
Intervention Description
Undergo gallium Ga 68-edotreotide PET/CT
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo gallium Ga 68-edotreotide PET/CT
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo gallium Ga 68-edotreotide PET/CT
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide
Description
The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).
Time Frame
Baseline up to 30 days
Title
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Sue O'Dorisio, MD, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
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