Recurrent High Grade GliomasNCT00942760
Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
An observational study of Recurrent High Grade Gliomas, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High Grade Gliomas
- What is being tested?
- 3T MRI
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2011
- 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: Recurrent GBM patients
Who may be able to join
- Histologically proven high grae glioma with central pathology review at DHMC
- Age 18 equal to or greater than 18 years
- Karnofsky performance greater or equal to 60%
- Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy.
Who cannot join
- Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
- Pregnant women are not eligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.
- Conditions
- Recurrent High Grade Gliomas
- Being tested
- 3T MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRIDevice
The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.
| Study group | Role | What they receive |
|---|---|---|
| Research MRI | High Grade Glioma patients who show progression based on MRI Receives: Device: 3T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination.
Measured: 24 months
Secondary outcomes (1)
To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High Grade GliomasStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock 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
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942760
- Sponsor's protocol ID
- D0901
- Other IDs
- DMS-0901
- Status last verified
- Jul 2012
- First submitted
- 20 Jul 2009
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
- ClinicalTrials.gov ID
- NCT00942760
- Acronym / sponsor ID
- D0901
- Conditions
- Recurrent High Grade Gliomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Jul 2009 (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.
Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research MRI | – | Device: 3T MRIHigh Grade Glioma patients who show progression based on MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent GBM patients
Key inclusion criteria (4 listed)
- Histologically proven high grae glioma with central pathology review at DHMC
- Age 18 equal to or greater than 18 years
- Karnofsky performance greater or equal to 60%
- Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy.
Key exclusion criteria (2 listed)
- Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
- Pregnant women are not eligible
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 MRIThe introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology. | Device | Research MRI |
Primary outcome
To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination.
Time frame: 24 months
1 secondary outcome
To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T
Time frame: 24 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 8 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recurrent High Grade Gliomas, run by Dartmouth-Hitchcock 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 4 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 8 May 2013. 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?
To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination. (time frame: 24 months). 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 8 May 2013.