High Grade GliomaNCT01191346
Radiation Planning Study for High Grade Brain Tumors
An observational study of High Grade Glioma, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- 3T MRI
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Mar 2013
- 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 with high grade glioma planning to receive radiation therapy
Who may be able to join
- Histologically confirmed, newly diagnosed Grade III-IV glioma
- Planning to undergo radiation therapy
Who cannot join
- Grade I or II glioma
- Patients unable to undergo MRI imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3T Versus 1.5T MR Approaches in Target Definition for Malignant Gliomas: Is There a Significant Difference in Tumor Extent and Radiation Treatment Volume?
The purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future.
- Conditions
- High Grade Glioma
- Being tested
- 3T MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRIOther
3T MRI in addition to standard 1.5T MRI for treatment planning
| Study group | Role | What they receive |
|---|---|---|
| 3T MRI | Patients receiving 3T MRI Receives: Other: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment volume
To assess the difference in treatment volume for radiation planning in gliomas as calculated using 1.5T versus 3T magnets
Measured: 1 year average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Kastl, BS, CCRC, University of Cincinnati
- Investigators
- Jessica Guarnaschelli, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191346
- Sponsor's protocol ID
- BTC-G1
- Status last verified
- Dec 2014
- First submitted
- 25 Aug 2010
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3T Versus 1.5T MR Approaches in Target Definition for Malignant Gliomas: Is There a Significant Difference in Tumor Extent and Radiation Treatment Volume?
- ClinicalTrials.gov ID
- NCT01191346
- Acronym / sponsor ID
- BTC-G1
- Conditions
- High Grade Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Aug 2010 (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 purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3T MRI | – | Other: 3T MRIPatients receiving 3T MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high grade glioma planning to receive radiation therapy
Key inclusion criteria (2 listed)
- Histologically confirmed, newly diagnosed Grade III-IV glioma
- Planning to undergo radiation therapy
Key exclusion criteria (2 listed)
- Grade I or II glioma
- Patients unable to undergo MRI imaging
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 |
|---|---|---|
| 3T MRI3T MRI in addition to standard 1.5T MRI for treatment planning | Other | 3T MRI |
Primary outcome
Treatment volume
Time frame: 1 year average
To assess the difference in treatment volume for radiation planning in gliomas as calculated using 1.5T versus 3T magnets
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 22 Aug 2017.
- Individual participant dataSharing planned: No
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Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High Grade Glioma
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A Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma.
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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.
Jessica Guarnaschelli, MD principal investigator
University of Cincinnati
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 High Grade Glioma, run by University of Cincinnati 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 2 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: finished, as of the sponsor's last update on 22 Aug 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 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?
Treatment volume (time frame: 1 year average). 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 22 Aug 2017.