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Trial record 37 of 55 for:    "Anaplastic oligoastrocytoma"

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

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ClinicalTrials.gov Identifier: NCT02194452
Recruitment Status : Withdrawn
First Posted : July 18, 2014
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Ride for Kids
Information provided by (Responsible Party):
Sue O'Dorisio, University of Iowa

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 18, 2014
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide [ Time Frame: Baseline up to 30 days ]
    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 [ Time Frame: Up to 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02194452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Official Title  ICMJE Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Radiation: gallium Ga 68-edotreotide
    Undergo gallium Ga 68-edotreotide PET/CT
    Other Name: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
  • Procedure: positron emission tomography
    Undergo gallium Ga 68-edotreotide PET/CT
    Other Name: FDG-PET, PET, PET scan, tomography, emission computed
  • Procedure: computed tomography
    Undergo gallium Ga 68-edotreotide PET/CT
    Other Name: tomography, computed
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE 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

Interventions:
  • Radiation: gallium Ga 68-edotreotide
  • Procedure: positron emission tomography
  • Procedure: computed tomography
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2014)
30
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 29 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02194452
Other Study ID Numbers  ICMJE 201302711
P30CA086862 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sue O'Dorisio, University of Iowa
Study Sponsor  ICMJE Sue O'Dorisio
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Ride for Kids
Investigators  ICMJE
Principal Investigator: M. Sue O'Dorisio, MD, PhD University of Iowa
PRS Account University of Iowa
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP