Brain TumorNCT02035852
High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
An observational study of Brain Tumor, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The study will compare two different size MRI's of a brain tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- MRI
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2009to 20 Apr 2018
- Phase
- Observational
- 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
Study population: Patients at the Simmons Cancer Center at UTSW
Who may be able to join
- Male or female, age 18 years or older
- Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
- Histological diagnosis of a brain tumor
- Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
- Pre-operative brain MR imaging suggestive of a brain tumor
- Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)
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- Patient able and willing to provide informed consent
- Karnofsky Performance status > 70%
- Life expectancy greater than 3 months
- Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
- Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T * Spanish speaking participants will be enrolled for this study
Who cannot join
- Body weight >137 Kg (300 lbs)
- Patient unable to provide informed consent
- Karnofsky Performance status < 70%
- Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
- NYHA class III and IV congestive heart failure
- Psychiatric or addictive disorders that preclude obtaining informed consent
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- Unstable angina
- Sexually active patients of childbearing potential not using a reliable contraceptive method
- Pregnant or lactating women
- Women of childbearing potential who refuse a pregnancy test (performed during screening)
Trial locations and contacts
1 site in 1 country.
About this study
The study will compare two different size MRI's of a brain tumor.
Read the detailed description
The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.
- Conditions
- Brain Tumor
- Being tested
- MRI
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
3T MRI vs. 7T MRI
| Study group | Role | What they receive |
|---|---|---|
| Adult Gilomas | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of 7T MR imaging
- To determine the benefit of 7T MR imaging in brain tumor patients with regard to the improvement in resolution, as measured by the area of T2 FLAIR signal abnormality and the ability to detect abnormalities in vascular integrity. The benefit will be determined at a single time point as well as longitudinally for each patient at 6 month intervals.
Measured: Baseline and 6 month intervals after baseline
Secondary outcomes (1)
Vascular Integrity
To determine if changes in vascular integrity at 7T can be correlated with tumor progression or transformation to high grade in patients with low grade gliomas.
Measured: Every 6 months, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study start28 Aug 2009
- Primary completion19 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Maher, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035852
- Sponsor's protocol ID
- STU 062010-160
- Other IDs
- 1R01CA154843-01A1
- Status last verified
- Nov 2018
- First submitted
- 12 Jun 2012
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Magnetic Resonance Imaging in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT02035852
- Acronym / sponsor ID
- STU 062010-160
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2009 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 14 Jan 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.
The study will compare two different size MRI's of a brain tumor.
Detailed description
The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRI in approximately 150 patients followed serially with MR imaging to evaluate for tumor progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Gilomas | – | Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Simmons Cancer Center at UTSW
Key inclusion criteria (11 listed)
- Male or female, age 18 years or older
- Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
- Histological diagnosis of a brain tumor
- Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
- Pre-operative brain MR imaging suggestive of a brain tumor
Key exclusion criteria (10 listed)
- Body weight >137 Kg (300 lbs)
- Patient unable to provide informed consent
- Karnofsky Performance status < 70%
- Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
- NYHA class III and IV congestive heart failure
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 |
|---|---|---|
| MRI3T MRI vs. 7T MRI | Other | Adult Gilomas |
Primary outcome
Benefit of 7T MR imaging
Time frame: Baseline and 6 month intervals after baseline
1. To determine the benefit of 7T MR imaging in brain tumor patients with regard to the improvement in resolution, as measured by the area of T2 FLAIR signal abnormality and the ability to detect abnormalities in vascular integrity. The benefit will be determined at a single time point as well as longitudinally for each patient at 6 month intervals.
1 secondary outcome
Vascular Integrity
Time frame: Every 6 months, up to 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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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.
Elizabeth Maher, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by University of Texas Southwestern Medical 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Benefit of 7T MR imaging (time frame: Baseline and 6 month intervals after 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 2 Jan 2019.