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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Months - 29 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02194452
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sue O'Dorisio
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

M. Sue O'Dorisio, MD, PhD
Principal Investigator Affiliation University of Iowa
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

Arms

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

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

Contact a Trial Team

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University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242