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

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

Sponsors

Lead Sponsor: Sue O'Dorisio

Collaborator: National Cancer Institute (NCI)
Ride for Kids

Source University of Iowa
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.

Overall Status Withdrawn
Start Date 2013-09-01
Completion Date 2017-03-01
Primary Completion Date 2017-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide Baseline up to 30 days
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy Up to 30 days
Condition
Intervention

Intervention Type: Radiation

Intervention Name: gallium Ga 68-edotreotide

Description: Undergo gallium Ga 68-edotreotide PET/CT

Arm Group Label: Diagnostic (gallium Ga 68-edotreotide PET/CT)

Other Name: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC

Intervention Type: Procedure

Intervention Name: positron emission tomography

Description: Undergo gallium Ga 68-edotreotide PET/CT

Arm Group Label: Diagnostic (gallium Ga 68-edotreotide PET/CT)

Other Name: FDG-PET, PET, PET scan, tomography, emission computed

Intervention Type: Procedure

Intervention Name: computed tomography

Description: Undergo gallium Ga 68-edotreotide PET/CT

Arm Group Label: Diagnostic (gallium Ga 68-edotreotide PET/CT)

Other Name: tomography, computed

Intervention Type: Other

Intervention Name: laboratory biomarker analysis

Description: Correlative studies

Arm Group Label: Diagnostic (gallium Ga 68-edotreotide PET/CT)

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

Gender:

All

Minimum Age:

6 Months

Maximum Age:

29 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
M. Sue O'Dorisio, MD, PhD Principal Investigator University of Iowa
Location
Facility: University of Iowa Hospitals and Clinics
Location Countries

United States

Verification Date

2017-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Iowa

Investigator Full Name: Sue O'Dorisio

Investigator Title: Professor Pediatrics-HEM-Oncology

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Diagnostic (gallium Ga 68-edotreotide PET/CT)

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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