NCT02194452

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

July 16, 2014

Last Update Submit

April 27, 2017

Conditions

Acoustic SchwannomaAdult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic MeningiomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Choroid Plexus TumorAdult CraniopharyngiomaAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Grade I MeningiomaAdult Grade II MeningiomaAdult MedulloblastomaAdult Meningeal HemangiopericytomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Papillary MeningiomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult PineoblastomaAdult PineocytomaAdult Subependymal Giant Cell AstrocytomaAdult SubependymomaAdult Supratentorial Primitive Neuroectodermal Tumor (PNET)Childhood Choroid Plexus TumorChildhood CraniopharyngiomaChildhood EpendymoblastomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral AstrocytomaChildhood Infratentorial EpendymomaChildhood Low-grade Cerebellar AstrocytomaChildhood Low-grade Cerebral AstrocytomaChildhood MedulloepitheliomaChildhood Supratentorial EpendymomaMeningeal MelanocytomaNewly Diagnosed Childhood EpendymomaRecurrent Adult Brain TumorRecurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood Diffuse AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Fibrillary AstrocytomaRecurrent Childhood Gemistocytic AstrocytomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood GliosarcomaRecurrent Childhood MedulloblastomaRecurrent Childhood OligoastrocytomaRecurrent Childhood OligodendrogliomaRecurrent Childhood Pilocytic AstrocytomaRecurrent Childhood Pilomyxoid AstrocytomaRecurrent Childhood PineoblastomaRecurrent Childhood Pleomorphic XanthoastrocytomaRecurrent Childhood Protoplasmic AstrocytomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaUntreated Childhood Anaplastic AstrocytomaUntreated Childhood Anaplastic OligodendrogliomaUntreated Childhood Brain Stem GliomaUntreated Childhood Cerebellar AstrocytomaUntreated Childhood Cerebral AstrocytomaUntreated Childhood Diffuse AstrocytomaUntreated Childhood Fibrillary AstrocytomaUntreated Childhood Gemistocytic AstrocytomaUntreated Childhood Giant Cell GlioblastomaUntreated Childhood GlioblastomaUntreated Childhood Gliomatosis CerebriUntreated Childhood GliosarcomaUntreated Childhood MedulloblastomaUntreated Childhood OligoastrocytomaUntreated Childhood OligodendrogliomaUntreated Childhood Pilocytic AstrocytomaUntreated Childhood Pilomyxoid AstrocytomaUntreated Childhood PineoblastomaUntreated Childhood Pleomorphic XanthoastrocytomaUntreated Childhood Protoplasmic AstrocytomaUntreated Childhood Subependymal Giant Cell AstrocytomaUntreated Childhood Supratentorial Primitive Neuroectodermal TumorUntreated Childhood Visual Pathway and Hypothalamic GliomaUntreated Childhood Visual Pathway Glioma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Diagnostic (gallium Ga 68-edotreotide PET/CT)

EXPERIMENTAL

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

Radiation: gallium Ga 68-edotreotideProcedure: positron emission tomographyProcedure: computed tomographyOther: laboratory biomarker analysis

Interventions

gallium Ga 68-edotreotideRADIATION

Undergo gallium Ga 68-edotreotide PET/CT

Also known as: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
Diagnostic (gallium Ga 68-edotreotide PET/CT)
positron emission tomographyPROCEDURE

Undergo gallium Ga 68-edotreotide PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (gallium Ga 68-edotreotide PET/CT)
computed tomographyPROCEDURE

Undergo gallium Ga 68-edotreotide PET/CT

Also known as: tomography, computed
Diagnostic (gallium Ga 68-edotreotide PET/CT)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (gallium Ga 68-edotreotide PET/CT)

Eligibility Criteria

Age6 Months - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neuroma, AcousticAstrocytomaEpendymomaMeningiomaOligodendrogliomaChoroid Plexus NeoplasmsCraniopharyngiomaNeuroectodermal Tumors, PrimitiveGlioblastomaGliosarcomaMedulloblastomaGliomaPinealomaGlioma, SubependymalBrain NeoplasmsFamilial ependymomaNeoplasms, NeuroepithelialOptic Nerve Glioma

Interventions

gallium Ga 68 dotatateMagnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesNeoplasms, Glandular and EpithelialNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsCerebral Ventricle NeoplasmsBrain DiseasesCentral Nervous System DiseasesOptic Nerve NeoplasmsOptic Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • M. Sue O'Dorisio, MD, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Pediatrics-HEM-Oncology

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

US(1)