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

Not Applicable

Withdrawn

• Conditions: Adult Choroid Plexus Tumor; Adult Meningeal Hemangiopericytoma; Childhood Low-grade Cerebellar Astrocytoma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Gliomatosis Cerebri; Adult Anaplastic Astrocytoma; Adult Glioblastoma; Adult Medulloblastoma; Adult Myxopapillary Ependymoma; Adult Pineocytoma
• Interventions: Radiation: gallium Ga 68-edotreotide; Procedure: positron emission tomography; Procedure: computed tomography; Other: laboratory biomarker analysis

• Registration Number: NCT02194452
• Lead Sponsor: Sue O'Dorisio

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (gallium Ga 68-edotreotide PET/CT)	computed tomography	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
Diagnostic (gallium Ga 68-edotreotide PET/CT)	gallium Ga 68-edotreotide	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
Diagnostic (gallium Ga 68-edotreotide PET/CT)	positron emission tomography	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
Diagnostic (gallium Ga 68-edotreotide PET/CT)	laboratory biomarker analysis	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

Primary Outcome Measures

Name	Time	Method
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy	Up to 30 days
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide	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 -).

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States