GlioblastomaPhase 2NCT03137888
Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma
A Phase 2 study testing Dose-Escalated Radiation Therapy, Spectroscopic Magnetic Resonance Imaging and Temozolomide in people with Glioblastoma and Gliosarcoma, run by Emory University at 3 sites in United States.
Trial summary
This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma
- What is being tested?
- Dose-Escalated Radiation Therapy, Spectroscopic Magnetic Resonance Imaging and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Sep 2017to 9 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist
- Patients must be able to have MRI scans
- Patients must have the following lab values ≤ 14 days prior to registration:
- White blood cell (WBC) ≥ 3,000/µL
- Absolute neutrophil count (ANC) ≥ 1,500/µL
- Platelet count of ≥ 75,000/µL
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- Hemoglobin ≥ 9.0 gm/dL (transfusion is allowed to reach minimum level)
- Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0 x upper limit of normal (ULN)
- Bilirubin ≤ 2 x ULN
- Creatinine ≤ 1.5 mg/dL
- Patients must have a life expectancy of ≥ 12 weeks
- Patients must have a Karnofsky performance status (KPS) ≥ 60
- Patients who are women of childbearing potential must have a negative pregnancy test documented ≤ 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care
- Patients must be able to understand and provide written informed consent
- Members of all races and ethnic groups are eligible for this trial; subjects will be approximately representative of the demographics of the referral base for the participating institutions
- Patient must be able to swallow capsules
- Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
Who cannot join
- Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
- Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded
- Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible
- Patients with an active infection or serious intercurrent medical illness are ineligible
- Patients receiving any other investigational agents are excluded
- Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
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- Patients with a history of prior cranial radiation are ineligible
- Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy
- Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum
- The maximum radiation target volume for gross tumor volume 3 (GTV3) is 65 cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV3 volume is greater than 65 cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than 20 cc)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
About this study
Official title: Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma
This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s.
II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs.
SECONDARY OBJECTIVE:
- To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs.
TERTIARY OBJECTIVES:
- To determine whether sMRI-guided, dose-escalated RT increases the overall survival of patients with newly diagnosed GBMs.
II. To determine whether sMRI data obtained after initiation of therapy (at 2 weeks after RT/TMZ start and prior to cycle 1 and 5 of adjuvant temozolomide [TMZ]) will provide early evidence of GBM progression not seen on standard MRIs.
III. To determine whether performance on neurocognitive and quality-of-life (QOL) assessments in newly-diagnosed GBM patients treated with sMRI-guided, dose-escalated RT differ from historical controls.
OUTLINE:
Patients undergo sMRI-guided radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide orally (PO) daily during radiation therapy for up to 42 days.
After completion of study treatment, patients are followed up every 3 months for up to 2 years and then periodically.
- Conditions
- Glioblastoma, Gliosarcoma
- Being tested
- Dose-Escalated Radiation Therapy, Spectroscopic Magnetic Resonance Imaging, Temozolomide
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-Escalated Radiation TherapyRadiation
Also called RT, Radiation Therapy
Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance ImagingProcedure or surgery
Also called sMRI, MRSI, Magnetic Resonance Spectroscopic Imaging
Patients will undergo sMRI scans within a 14 day window prior to starting treatment
TemozolomideDrug
Also called Methazolastone, Temcad, Temodal, Temodar
Given PO
| Study group | Role | What they receive |
|---|---|---|
| sMRI-Guided RT with TMZ | Experimental | Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days. Receives: Radiation: Dose-Escalated Radiation Therapy; Procedure: Spectroscopic Magnetic Resonance Imaging; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment.
Measured: Up to 2 years after completion of therapy
Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0
The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
Measured: Up to 2 years after completion of therapy
Secondary outcomes (1)
Progression Free Survival (PFS)
Patients were followed at least every 3 months for 2 years from the start of RT.
Measured: 2 years from the start of RT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start20 Sep 2017
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Emory 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Miami, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hui-Kuo Shu, Emory University
- Investigators
- Hui-Kuo Shu, MD, PhD, Principal investigator, Emory University/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137888
- Sponsor's protocol ID
- IRB00094188
- Other IDs
- NCI-2017-00424, RAD3383-17, R01CA214557, P30CA138292
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2017
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trivedi AG, Kim SH, Ramesh KK, Giuffrida AS, Weinberg BD, Mellon EA, Kleinberg LR, Barker PB, Han H, Shu HG, Shim H, Schreibmann E. Applying a Radiation Therapy Volume Analysis Pipeline to Determine the Utility of Spectroscopic MRI-Guided Adaptive Radiation Therapy for Glioblastoma. Tomography. 2023 May 21;9(3):1052-1061. doi: 10.3390/tomography9030086.
PubMed 37218946Ramesh K, Gurbani SS, Mellon EA, Huang V, Goryawala M, Barker PB, Kleinberg L, Shu HG, Shim H, Weinberg BD. The Longitudinal Imaging Tracker (BrICS-LIT):A Cloud Platform for Monitoring Treatment Response in Glioblastoma Patients. Tomography. 2020 Jun;6(2):93-100. doi: 10.18383/j.tom.2020.00001.
PubMed 32548285Gurbani S, Weinberg B, Cooper L, Mellon E, Schreibmann E, Sheriff S, Maudsley A, Goryawala M, Shu HK, Shim H. The Brain Imaging Collaboration Suite (BrICS): A Cloud Platform for Integrating Whole-Brain Spectroscopic MRI into the Radiation Therapy Planning Workflow. Tomography. 2019 Mar;5(1):184-191. doi: 10.18383/j.tom.2018.00028.
PubMed 30854456
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03137888
- Acronym / sponsor ID
- IRB00094188
- Conditions
- Glioblastoma, Gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Miami, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 3 Aug 2025
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 the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s.
II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs.
SECONDARY OBJECTIVE:
- To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs.
TERTIARY OBJECTIVES:
- To determine whether sMRI-guided, dose-escalated RT increases the overall survival of patients with newly diagnosed GBMs.
II. To determine whether sMRI data obtained after initiation of therapy (at 2 weeks after RT/TMZ start and prior to cycle 1 and 5 of adjuvant temozolomide [TMZ]) will provide early evidence of GBM progression not seen on standard MRIs.
III. To determine whether performance on neurocognitive and quality-of-life (QOL) assessments in newly-diagnosed GBM patients treated with sMRI-guided, dose-escalated RT differ from historical controls.
OUTLINE:
Patients undergo sMRI-guided radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide orally (PO) daily during radiation therapy for up to 42 days.
After completion of study treatment, patients are followed up every 3 months for up to 2 years and then periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sMRI-Guided RT with TMZ | Experimental | Radiation: Dose-Escalated Radiation Therapy, Procedure: Spectroscopic Magnetic Resonance Imaging, Drug: TemozolomidePatients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist
- Patients must be able to have MRI scans
- Patients must have the following lab values ≤ 14 days prior to registration:
- Patients must have a life expectancy of ≥ 12 weeks
- Patients must have a Karnofsky performance status (KPS) ≥ 60
Key exclusion criteria (10 listed)
- Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
- Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded
- Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible
- Patients with an active infection or serious intercurrent medical illness are ineligible
- Patients receiving any other investigational agents are excluded
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 |
|---|---|---|
| Dose-Escalated Radiation TherapyAlso: RT, Radiation TherapyUndergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks | Radiation | sMRI-Guided RT with TMZ |
| Spectroscopic Magnetic Resonance ImagingAlso: sMRI, MRSI, Magnetic Resonance Spectroscopic ImagingPatients will undergo sMRI scans within a 14 day window prior to starting treatment | Procedure or surgery | sMRI-Guided RT with TMZ |
| TemozolomideAlso: Methazolastone, Temcad, Temodal, TemodarGiven PO | Drug | sMRI-Guided RT with TMZ |
Primary outcome
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
Time frame: Up to 2 years after completion of therapy
Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment.
Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 2 years after completion of therapy
The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
1 secondary outcome
Progression Free Survival (PFS)
Time frame: 2 years from the start of RT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37218946Trivedi AG, Kim SH, Ramesh KK, Giuffrida AS, Weinberg BD, Mellon EA, Kleinberg LR, Barker PB, Han H, Shu HG, Shim H, Schreibmann E. Applying a Radiation Therapy Volume Analysis Pipeline to Determine the Utility of Spectroscopic MRI-Guided Adaptive Radiation Therapy for Glioblastoma. Tomography. 2023 May 21;9(3):1052-1061. doi: 10.3390/tomography9030086.
- Derived from this study: PubMed 32548285Ramesh K, Gurbani SS, Mellon EA, Huang V, Goryawala M, Barker PB, Kleinberg L, Shu HG, Shim H, Weinberg BD. The Longitudinal Imaging Tracker (BrICS-LIT):A Cloud Platform for Monitoring Treatment Response in Glioblastoma Patients. Tomography. 2020 Jun;6(2):93-100. doi: 10.18383/j.tom.2020.00001.
- Derived from this study: PubMed 30854456Gurbani S, Weinberg B, Cooper L, Mellon E, Schreibmann E, Sheriff S, Maudsley A, Goryawala M, Shu HK, Shim H. The Brain Imaging Collaboration Suite (BrICS): A Cloud Platform for Integrating Whole-Brain Spectroscopic MRI into the Radiation Therapy Planning Workflow. Tomography. 2019 Mar;5(1):184-191. doi: 10.18383/j.tom.2018.00028.
- Individual participant dataSharing planned: No
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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.
Hui-Kuo Shu, MD, PhD principal investigator
Emory University/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose-Escalated Radiation Therapy, Spectroscopic Magnetic Resonance Imaging and Temozolomide in people with Glioblastoma and Gliosarcoma, run by Emory University at 3 sites 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 17 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform (time frame: Up to 2 years after completion of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137888, which also lists 3 linked publications.
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 3 Aug 2025.