GlioblastomaNCT02590497
Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery
A study testing Diffusion Weighted Imaging, Gadolinium and Laboratory Biomarker Analysis in people with Glioblastoma, run by Ohio State University Comprehensive Cancer Center.
Trial summary
This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Diffusion Weighted Imaging, Gadolinium and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2016to 26 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will be undergoing surgery for newly-diagnosed glioblastoma
- Subtotal, gross total or biopsy patients will be eligible
- Confirmation of pathology as glioblastoma
Who cannot join
- Tissue analysis demonstrating pathology other than glioblastoma
- Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
About this study
Official title: The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma
This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the correlation between the genetic and neuroimaging signature of glioblastoma.
II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis.
OUTLINE:
Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.
- Conditions
- Glioblastoma
- Being tested
- Diffusion Weighted Imaging, Gadolinium, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Perfusion Magnetic Resonance Imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Weighted ImagingProcedure or surgery
Also called Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI
Undergo diffusion weighted MRI
GadoliniumDrug
Also called Gd
Undergo gadolinium-enhanced MRI
Laboratory Biomarker AnalysisOther
Tissue genetic analysis
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo gadolinium-enhanced MRI
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo 3D volumetric T1-weighted sequence
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo FLAIR sequence
Perfusion Magnetic Resonance ImagingProcedure or surgery
Also called magnetic resonance perfusion imaging
Undergo perfusion MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (MRI, tumor tissue analysis) | Experimental | Patients undergo MRI before and after gadolinium contrast administration, including 3D volumetric T1-weighted sequence, FLAIR sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile. Receives: Procedure: Diffusion Weighted Imaging; Drug: Gadolinium; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Perfusion Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in OSU and 1.5 T in MUSC) will be explored in each class of patients.
Measured: Day 1
Diffusional kurtosis (DK) values
The average DK parameter and cerebral blood volume (CBV) parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in Ohio State University [OSU] and 1.5 T in Medical University of South Carolina [MUSC]) will be explored in each class of patients.
Measured: Day 1
Genetic tumor profile
The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start20 Mar 2016
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Why it stopped: PI made decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Giglio, Ohio State University Comprehensive Cancer Center
- Investigators
- Pierre Giglio, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590497
- Sponsor's protocol ID
- OSU-15019
- Other IDs
- NCI-2015-00873
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT02590497
- Acronym / sponsor ID
- OSU-15019
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI made decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 29 Oct 2015 (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 the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.
Detailed description
PRIMARY OBJECTIVES:
- Determine the correlation between the genetic and neuroimaging signature of glioblastoma.
II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis.
OUTLINE:
Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI, tumor tissue analysis) | Experimental | Procedure: Diffusion Weighted Imaging, Drug: Gadolinium, Other: Laboratory Biomarker Analysis, Procedure: Magnetic Resonance Imaging, Procedure: Perfusion Magnetic Resonance ImagingPatients undergo MRI before and after gadolinium contrast administration, including 3D volumetric T1-weighted sequence, FLAIR sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be undergoing surgery for newly-diagnosed glioblastoma
- Subtotal, gross total or biopsy patients will be eligible
- Confirmation of pathology as glioblastoma
Key exclusion criteria (2 listed)
- Tissue analysis demonstrating pathology other than glioblastoma
- Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
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 |
|---|---|---|
| Diffusion Weighted ImagingAlso: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRIUndergo diffusion weighted MRI | Procedure or surgery | Diagnostic (MRI, tumor tissue analysis) |
| GadoliniumAlso: GdUndergo gadolinium-enhanced MRI | Drug | Diagnostic (MRI, tumor tissue analysis) |
| Laboratory Biomarker AnalysisTissue genetic analysis | Other | Diagnostic (MRI, tumor tissue analysis) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo gadolinium-enhanced MRI | Procedure or surgery | Diagnostic (MRI, tumor tissue analysis) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo 3D volumetric T1-weighted sequence | Procedure or surgery | Diagnostic (MRI, tumor tissue analysis) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo FLAIR sequence | Procedure or surgery | Diagnostic (MRI, tumor tissue analysis) |
| Perfusion Magnetic Resonance ImagingAlso: magnetic resonance perfusion imagingUndergo perfusion MRI | Procedure or surgery | Diagnostic (MRI, tumor tissue analysis) |
Primary outcome
Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis
Time frame: Day 1
The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in OSU and 1.5 T in MUSC) will be explored in each class of patients.
Diffusional kurtosis (DK) values
Time frame: Day 1
The average DK parameter and cerebral blood volume (CBV) parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary. Differences in DK and CBV parameters between the two MR techniques (3T MR in Ohio State University [OSU] and 1.5 T in Medical University of South Carolina [MUSC]) will be explored in each class of patients.
Genetic tumor profile
Time frame: Day 1
The average DK parameter and CBV parameter will be compared between classes 1 and 2 based on the 9-gene expression profile at each site using two sample t-test. Data will be transformed or a nonparametric test will be conducted if necessary.
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 31 Jan 2018.
- The JameslineLink provided by the sponsor.
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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.
Pierre Giglio, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Weighted Imaging, Gadolinium and Laboratory Biomarker Analysis in people with Glioblastoma, run by Ohio State University Comprehensive Cancer Center.
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 3 inclusion and 2 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between the genetic and neuroimaging signature of glioblastoma and prognosis (time frame: Day 1). The study lists 3 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 31 Jan 2018.