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
Acronym
Not provided
Organization
University of IowaOTHER
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Withdrawn
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2013
Primary Completion Date
Mar 2017Actual
Completion Date
Mar 2017Actual
First Submitted Date
Jul 16, 2014
First Submission Date that Met QC Criteria
Jul 16, 2014
First Posted Date
Jul 18, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 27, 2017
Last Update Posted Date
Apr 28, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sue O'Dorisio, Professor Pediatrics-HEM-Oncology, University of IowaSponsor-Investigator
Lead Sponsor
Sue O'DorisioOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Ride for Kids
UNKNOWN
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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