Acoustic SchwannomaNCT02194452
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
A study testing gallium Ga 68-edotreotide, positron emission tomography and computed tomography in people with Acoustic Schwannoma and Adult Anaplastic Astrocytoma, run by Sue O'Dorisio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 29 years
- Conditions the study is for
- Acoustic Schwannoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma
- What is being tested?
- gallium Ga 68-edotreotide, positron emission tomography and computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Acoustic Schwannoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma
- Being tested
- gallium Ga 68-edotreotide, positron emission tomography, computed tomography, laboratory biomarker analysis
- Medical subject headings
- Neuroma, Acoustic, Astrocytoma, Ependymoma, Meningioma, Oligodendroglioma, Choroid Plexus Neoplasms, Craniopharyngioma, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallium Ga 68-edotreotideRadiation
Also called Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
Undergo gallium Ga 68-edotreotide PET/CT
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo gallium Ga 68-edotreotide PET/CT
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo gallium Ga 68-edotreotide PET/CT
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: gallium Ga 68-edotreotide; Procedure: positron emission tomography; Procedure: computed tomography; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 -).
Measured: Baseline up to 30 days
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acoustic SchwannomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sue O'Dorisio
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ride for Kids
- Responsible party
- Sponsor-investigator, Sue O'Dorisio, University of Iowa
- Investigators
- M. Sue O'Dorisio, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194452
- Sponsor's protocol ID
- 201302711
- Other IDs
- P30CA086862
- Status last verified
- Apr 2017
- First submitted
- 16 Jul 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
- ClinicalTrials.gov ID
- NCT02194452
- Acronym / sponsor ID
- 201302711
- Conditions
- Acoustic Schwannoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sue O'DorisioUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ride for Kids
- Study start
- Sep 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (gallium Ga 68-edotreotide PET/CT) | Experimental | Radiation: gallium Ga 68-edotreotide, Procedure: positron emission tomography, Procedure: computed tomography, Other: laboratory biomarker analysisPatients 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 |
Who may qualify
- Ages
- 6 months to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gallium Ga 68-edotreotideAlso: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOCUndergo gallium Ga 68-edotreotide PET/CT | Radiation | Diagnostic (gallium Ga 68-edotreotide PET/CT) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo gallium Ga 68-edotreotide PET/CT | Procedure or surgery | Diagnostic (gallium Ga 68-edotreotide PET/CT) |
| computed tomographyAlso: tomography, computedUndergo gallium Ga 68-edotreotide PET/CT | Procedure or surgery | Diagnostic (gallium Ga 68-edotreotide PET/CT) |
| laboratory biomarker analysisCorrelative studies | Other | Diagnostic (gallium Ga 68-edotreotide PET/CT) |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Sue O'Dorisio, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gallium Ga 68-edotreotide, positron emission tomography and computed tomography in people with Acoustic Schwannoma and Adult Anaplastic Astrocytoma, run by Sue O'Dorisio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide (time frame: Baseline up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.