Tumors Metastatic to BrainNCT02269111
Quantitative MRI in Assessing Disease in Patients With Brain Tumors
A study testing diffusion-weighted magnetic resonance imaging, chemical exchange saturation transfer magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors Metastatic to Brain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- diffusion-weighted magnetic resonance imaging, chemical exchange saturation transfer magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign an Institutional Review Board (IRB)-approved informed consent document
- Patients must have been diagnosed with one of the following:
- Primary brain tumor (glioma, GBM etc); or
- Up to 10 brain metastases
- Patients must have been diagnosed with 1-4 brain metastases
- At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane
Show all 10Show fewer
- Patients must be scheduled to undergo standard brain cancer interventions:
- Chemotherapy or targeted antiangiogenic therapy, in the case of primary brain tumor; or
- Stereotaxic radiotherapy (SRS) or whole brain radiotherapy (WBRT), in the case of brain metastases.
- Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be modified to also include pulse sequences with are for research only)
Who cannot join
- Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic).
- Patients who are scheduled to receive a 1.5T MRI exam
- Patients incapable of giving informed written consent, due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders.
- Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Quantitative High-Field Magnetic Resonance Imaging (MRI) for Assessing Brain Metastases
This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.
Read the detailed description
PRIMARY OBJECTIVES:
- To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).
OUTLINE:
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.
- Being tested
- diffusion-weighted magnetic resonance imaging, chemical exchange saturation transfer magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging, dynamic susceptibility contrast-enhanced magnetic resonance imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Undergo DW-MRI
chemical exchange saturation transfer magnetic resonance imagingProcedure or surgery
Also called CEST MRI
Undergo CEST-MRI
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Undergo DCE-MRI
dynamic susceptibility contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DSC-MRI
Undergo DSC-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (hybrid MRI) | Experimental | Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline. Receives: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: chemical exchange saturation transfer magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume transfer constant (Ktrans), as measured by DCE-MRI
The ability of pre-treatment estimates of Ktrans to predict objective tumor response by Response Evaluation Criteria in Solid Tumors or Macdonald criteria after therapy will be assessed using the proportional odds model.
Measured: Baseline
Secondary outcomes (7)
Amide proton transfer asymmetry (APTasym) as measured by CEST
Cox proportional hazards regression will be used to assess the association of APTasym with change in tumor size.
Measured: Baseline
Apparent diffusion coefficient (ADC), as measured by DW-MRI
Cox proportional hazards regression will be used to assess the association of ADC with change in tumor size.
Measured: Baseline
Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI
Cox proportional hazards regression will be used to assess the association of Ve with change in tumor size.
Measured: Baseline
Plasma volume fraction (Vp), as measured by DCE-MRI
Cox proportional hazards regression will be used to assess the association of Vp with change in tumor size.
Measured: Baseline
Cerebral blood volume (CBV), as measured by DSC-MRI
Cox proportional hazards regression will be used to assess the association of CBV with change in tumor size.
Measured: Baseline
Cerebral blood flow (CBF), as measured by DSC-MRI
Cox proportional hazards regression will be used to assess the association of CBF with change in tumor size.
Measured: Baseline
Mean transit time (MTT), as measured by DSC-MRI
Cox proportional hazards regression will be used to assess the association of MTT with change in tumor size.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionOct 2017
- Study completionMay 2018
Why it stopped: Change in PI and funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors Metastatic to BrainStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Albert Attia, Vanderbilt-Ingram Cancer Center
- Investigators
- Albert Attia, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269111
- Sponsor's protocol ID
- VICC NEU1424
- Other IDs
- NCI-2014-01907, VICC NEU1424, P30CA068485
- Status last verified
- May 2018
- First submitted
- 15 Oct 2014
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative High-Field Magnetic Resonance Imaging (MRI) for Assessing Brain Metastases
- ClinicalTrials.gov ID
- NCT02269111
- Acronym / sponsor ID
- VICC NEU1424
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in PI and funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 20 Oct 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 quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.
Detailed description
PRIMARY OBJECTIVES:
- To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).
OUTLINE:
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (hybrid MRI) | Experimental | Procedure: diffusion-weighted magnetic resonance imaging, Procedure: chemical exchange saturation transfer magnetic resonance imaging, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: dynamic susceptibility contrast-enhanced magnetic resonance imagingPatients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must sign an Institutional Review Board (IRB)-approved informed consent document
- Patients must have been diagnosed with one of the following:
- Patients must have been diagnosed with 1-4 brain metastases
- At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane
- Patients must be scheduled to undergo standard brain cancer interventions:
Key exclusion criteria (4 listed)
- Patients who have received previous treatment (chemotherapy or radiotherapy) for any brain tumor (primary or metastatic).
- Patients who are scheduled to receive a 1.5T MRI exam
- Patients incapable of giving informed written consent, due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders.
- Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on the study
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 magnetic resonance imagingAlso: diffusion-weighted MRIUndergo DW-MRI | Procedure or surgery | Diagnostic (hybrid MRI) |
| chemical exchange saturation transfer magnetic resonance imagingAlso: CEST MRIUndergo CEST-MRI | Procedure or surgery | Diagnostic (hybrid MRI) |
| dynamic contrast-enhanced magnetic resonance imagingAlso: DCE-MRIUndergo DCE-MRI | Procedure or surgery | Diagnostic (hybrid MRI) |
| dynamic susceptibility contrast-enhanced magnetic resonance imagingAlso: DSC-MRIUndergo DSC-MRI | Procedure or surgery | Diagnostic (hybrid MRI) |
Primary outcome
Volume transfer constant (Ktrans), as measured by DCE-MRI
Time frame: Baseline
The ability of pre-treatment estimates of Ktrans to predict objective tumor response by Response Evaluation Criteria in Solid Tumors or Macdonald criteria after therapy will be assessed using the proportional odds model.
7 secondary outcomes
Amide proton transfer asymmetry (APTasym) as measured by CEST
Time frame: Baseline
Apparent diffusion coefficient (ADC), as measured by DW-MRI
Time frame: Baseline
Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI
Time frame: Baseline
Plasma volume fraction (Vp), as measured by DCE-MRI
Time frame: Baseline
Cerebral blood volume (CBV), as measured by DSC-MRI
Time frame: Baseline
Cerebral blood flow (CBF), as measured by DSC-MRI
Time frame: Baseline
Mean transit time (MTT), as measured by DSC-MRI
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Change in PI and funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
Albert Attia, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted magnetic resonance imaging, chemical exchange saturation transfer magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Vanderbilt-Ingram Cancer Center 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 10 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: stopped early, as of the sponsor's last update on 29 May 2018. 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 stopped early (reason given: Change in PI and funding). Results are not available in the source record.
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?
Volume transfer constant (Ktrans), as measured by DCE-MRI (time frame: Baseline). 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 29 May 2018.