A Phase 2 interventional study of Dose-Escalated Radiation Therapy and Spectroscopic Magnetic Resonance Imaging in Glioblastoma and Gliosarcoma, sponsored by Emory University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Emory University · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. 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:
I. To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs.
TERTIARY OBJECTIVES:
I. 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.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 30 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have the following lab values ≤ 14 days prior to registration:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: Dose-Escalated Radiation Therapy · Procedure: Spectroscopic Magnetic Resonance Imaging · Drug: Temozolomide
Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Also known as: RT, Radiation Therapy
Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Also known as: sMRI, MRSI, Magnetic Resonance Spectroscopic Imaging
Given PO
Also known as: Methazolastone, Temcad, Temodal, Temodar, Temomedac, TMZ
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.
Time frame: 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.
Time frame: Up to 2 years after completion of therapy
Progression Free Survival (PFS)
Patients were followed at least every 3 months for 2 years from the start of RT.
Time frame: 2 years from the start of RT.
Overall Survival (OS)
Patients were followed at least every 3 months for 2.5 years from the start of RT.
Time frame: 2.5 years from start of RT
| Milestone | sMRI-Guided RT With TMZ |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| Participants | sMRI-Guided RT With TMZ |
|---|---|
| Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform | 30 |
The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
| Adverse Events | sMRI-Guided RT With TMZ |
|---|---|
| Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0 | 79 (62 to 99) |
Patients were followed at least every 3 months for 2 years from the start of RT.
| Months | sMRI-Guided RT With TMZ |
|---|---|
| Progression Free Survival (PFS) | 16.6 (11.6 to 24.0) |
Patients were followed at least every 3 months for 2.5 years from the start of RT.
| Months | sMRI-Guided RT With TMZ |
|---|---|
| Overall Survival (OS) | 23 (18.6 to 27.3) |
Collected over Up to 2 years after completion of therapy. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| sMRI-Guided RT With TMZ | 16/30 (53.3%) | 14/30 (46.7%) | 30/30 (100%) |
| Event | sMRI-Guided RT With TMZ |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 5/30 |
| Muscle weaknessMusculoskeletal and connective tissue disorders | 2/30 |
| NeutropeniaImmune system disorders | 1/30 |
| TransaminitisBlood and lymphatic system disorders | 1/30 |
| HypokalemiaMetabolism and nutrition disorders | 1/30 |
| EdemaGeneral disorders | 1/30 |
| FatigueGeneral disorders | 1/30 |
| HeadachesNervous system disorders | 1/30 |
| Leg edemaGeneral disorders | 1/30 |
| Event | sMRI-Guided RT With TMZ |
|---|---|
| FatigueGeneral disorders | 28/30 |
| General disorders and administration site conditionsGeneral disorders | 19/30 |
| ConstipationGastrointestinal disorders | 16/30 |
| SeizureNervous system disorders | 15/30 |
| AlopeciaSkin and subcutaneous tissue disorders | 14/30 |
| HeadacheNervous system disorders | 14/30 |
| Nervous system disordersNervous system disorders | 13/30 |
| AnorexiaMetabolism and nutrition disorders | 12/30 |
| Blood and lymphatic system disorders - Other, specifyBlood and lymphatic system disorders | 12/30 |
| NauseaGastrointestinal disorders | 11/30 |
| Age, Categorical(Participants) | sMRI-Guided RT With TMZ |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 7 |
| Age, Continuous(Years) | sMRI-Guided RT With TMZ |
|---|---|
| Mean | 56.4 (20.8 to 71.6) |
| Sex: Female, Male(Participants) | sMRI-Guided RT With TMZ |
|---|---|
| Female | 11 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | sMRI-Guided RT With TMZ |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | sMRI-Guided RT With TMZ |
|---|---|
| United States | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Sep 2024, 83 months.
Results were first posted in Aug 2025, 10 months after primary completion.
Of 198 non-industry phase 2 interventional studies under Glioblastoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's 83 months is above that.
Counting every sponsor, half of 249 studies reached it within 56 months; a quarter within 40 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Temozolomide