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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

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.

Interventions

  • Radiation: gallium Ga 68-edotreotide
    • Undergo gallium Ga 68-edotreotide PET/CT
  • Procedure: positron emission tomography
    • Undergo gallium Ga 68-edotreotide PET/CT
  • Procedure: computed tomography
    • Undergo gallium Ga 68-edotreotide PET/CT
  • Other: laboratory biomarker analysis
    • Correlative studies

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 29 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sue O’Dorisio
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sue O’Dorisio, Professor Pediatrics-HEM-Oncology – University of Iowa
  • Overall Official(s)
    • M. Sue O’Dorisio, MD, PhD, Principal Investigator, University of Iowa

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