GlioblastomaNCT06108206
Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma
An observational study of Glioblastoma and Anaplastic Astrocytoma, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Anaplastic Astrocytoma, Astrocytoma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Residents of New York or commutable distance for treatment and follow up.
Who may be able to join
- Histopathologically proven diagnosis of glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma
- History and physical examination within 28 days prior to enrollment
- Karnofsky performance status 70 or greater
- Age 18 years or greater
- Negative pregnancy test for females of childbearing potential before 1st research MRI, performed in accordance to institutional guidelines.
- Plan to receive standard of care 59.4-60 Gy in 30-33 fractions of radiotherapy. Glioblastoma patients over 65 year-old can receive standard of care hypofractionated radiotherapy including 40 Gy in 15 fractions.
Who cannot join
- Prior therapy for tumor except for biopsy or resection, including prior radiotherapy to the brain.
- Clinical or radiological evidence of metastatic disease outside the brain
- Prior malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
About this study
Official title: Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma
The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
Read the detailed description
Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data.
This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.
- Keywords
- Adaptive Radiotherapy, High-grade glioma, Perfusion-weighted imaging, Diffusion weighted imaging
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary high-grade glioma | Patients will receive standard of care radiotherapy over 30-33 once-daily fractions. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of progression of disease in patients with high-grade glioma.
To compare the volume of the current standard of care conedown volume definition with an MRI-based adaptive plan in predicting the location of disease progression in patients with high-grade glioma.
Measured: 3 years
Secondary outcomes (1)
Estimate the progression-free and overall survival in patient with high-grade glioma.
Assess the prognostic and predictive value of highly-diffusion weighted and perfusion-weighted imaging in estimating progression-free and overall survival in patients with high-grade glioma.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start30 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
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 Columbia UniversityThe 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
- 20 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Tony Jau Cheng Wang, Columbia University
- Investigators
- Tony J. Wang, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108206
- Sponsor's protocol ID
- AAAU2309
- Status last verified
- Aug 2026
- First submitted
- 23 Oct 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma
- ClinicalTrials.gov ID
- NCT06108206
- Acronym / sponsor ID
- AAAU2309
- Keywords
- Adaptive Radiotherapy, High-grade glioma, Perfusion-weighted imaging, Diffusion weighted imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- 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 study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
Detailed description
Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data.
This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary high-grade glioma | – | –Patients will receive standard of care radiotherapy over 30-33 once-daily fractions. Subjects receiving hypofractionated radiotherapy will receive radiotherapy per standard of care over 15 once-daily fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of New York or commutable distance for treatment and follow up.
Key inclusion criteria (6 listed)
- Histopathologically proven diagnosis of glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma
- History and physical examination within 28 days prior to enrollment
- Karnofsky performance status 70 or greater
- Age 18 years or greater
- Negative pregnancy test for females of childbearing potential before 1st research MRI, performed in accordance to institutional guidelines.
Key exclusion criteria (3 listed)
- Prior therapy for tumor except for biopsy or resection, including prior radiotherapy to the brain.
- Clinical or radiological evidence of metastatic disease outside the brain
- Prior malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of progression of disease in patients with high-grade glioma.
Time frame: 3 years
To compare the volume of the current standard of care conedown volume definition with an MRI-based adaptive plan in predicting the location of disease progression in patients with high-grade glioma.
1 secondary outcome
Estimate the progression-free and overall survival in patient with high-grade glioma.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Tony J. Wang, MD principal investigator
Columbia University
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 Glioblastoma and Anaplastic Astrocytoma, run by Columbia University 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prediction of progression of disease in patients with high-grade glioma. (time frame: 3 years). 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 19 Aug 2026.