Trial Outcomes & Findings for Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma (NCT NCT03137888)
NCT ID: NCT03137888
Last Updated: 2025-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 2 years after completion of therapy
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
sMRI-Guided RT With TMZ
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma
Baseline characteristics by cohort
| Measure |
sMRI-Guided RT With TMZ
n=30 Participants
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
56.4 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after completion of therapyFeasibility 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.
Outcome measures
| Measure |
sMRI-Guided RT With TMZ
n=30 Participants
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
|
30 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after completion of therapyThe safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
Outcome measures
| Measure |
sMRI-Guided RT With TMZ
n=30 Participants
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0
|
79 Adverse Events
Interval 62.0 to 99.0
|
SECONDARY outcome
Timeframe: 2 years from the start of RT.Patients were followed at least every 3 months for 2 years from the start of RT.
Outcome measures
| Measure |
sMRI-Guided RT With TMZ
n=30 Participants
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Progression Free Survival (PFS)
|
16.6 Months
Interval 11.6 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2.5 years from start of RTPatients were followed at least every 3 months for 2.5 years from the start of RT.
Outcome measures
| Measure |
sMRI-Guided RT With TMZ
n=30 Participants
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Overall Survival (OS)
|
23 Months
Interval 18.6 to 27.3
|
Adverse Events
sMRI-Guided RT With TMZ
Serious events: 14 serious events
Other events: 30 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
sMRI-Guided RT With TMZ
n=30 participants at risk
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Immune system disorders
Neutropenia
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Transaminitis
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
General disorders
Edema
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Headaches
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
|
General disorders
Leg edema
|
3.3%
1/30 • Number of events 1 • Up to 2 years after completion of therapy
|
Other adverse events
| Measure |
sMRI-Guided RT With TMZ
n=30 participants at risk
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.
Dose-Escalated Radiation Therapy: Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
Spectroscopic Magnetic Resonance Imaging: Patients will undergo sMRI scans within a 14 day window prior to starting treatment
Temozolomide: Given PO
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
13.3%
4/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Agitation
|
10.0%
3/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.7%
14/30 • Number of events 14 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
6/30 • Number of events 8 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
12/30 • Number of events 15 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Anxiety
|
26.7%
8/30 • Number of events 11 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
40.0%
12/30 • Number of events 16 • Up to 2 years after completion of therapy
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Concentration Impairment
|
13.3%
4/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Confusion
|
13.3%
4/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Constipation
|
53.3%
16/30 • Number of events 26 • Up to 2 years after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • Number of events 7 • Up to 2 years after completion of therapy
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Depressed level of consciousness
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Depression
|
26.7%
8/30 • Number of events 13 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
4/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Dysphasia
|
16.7%
5/30 • Number of events 8 • Up to 2 years after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
General disorders
Edema face
|
13.3%
4/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
General disorders
Edema limbs
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Endocrine disorders
Endocrine disorders
|
13.3%
4/30 • Number of events 7 • Up to 2 years after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
10.0%
3/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Eye disorders
Eye disorders
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
General disorders
Fatigue
|
93.3%
28/30 • Number of events 48 • Up to 2 years after completion of therapy
|
|
General disorders
Fever
|
13.3%
4/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Eye disorders
Floaters
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
General disorders
Flu like symptoms
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
General disorders
Gait disturbance
|
13.3%
4/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
General disorders
General disorders and administration site conditions
|
63.3%
19/30 • Number of events 33 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
5/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Headache
|
46.7%
14/30 • Number of events 24 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.3%
4/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
2/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Infections and infestations
Infections and infestations
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Insomnia
|
23.3%
7/30 • Number of events 9 • Up to 2 years after completion of therapy
|
|
Investigations
Investigations
|
6.7%
2/30 • Number of events 7 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Irritability
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Memory impairment
|
13.3%
4/30 • Number of events 8 • Up to 2 years after completion of therapy
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Muscle weakness right-sided
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
26.7%
8/30 • Number of events 12 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30 • Number of events 24 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Nervous system disorders
|
43.3%
13/30 • Number of events 29 • Up to 2 years after completion of therapy
|
|
General disorders
Pain
|
13.3%
4/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
3/30 • Number of events 4 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Paresthesia
|
13.3%
4/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
4/30 • Number of events 5 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Personality change
|
6.7%
2/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Investigations
Platelet count decreased
|
13.3%
4/30 • Number of events 13 • Up to 2 years after completion of therapy
|
|
Psychiatric disorders
Psychiatric disorders
|
10.0%
3/30 • Number of events 6 • Up to 2 years after completion of therapy
|
|
Renal and urinary disorders
Renal and urinary disorders
|
20.0%
6/30 • Number of events 9 • Up to 2 years after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Nervous system disorders
Seizure
|
50.0%
15/30 • Number of events 18 • Up to 2 years after completion of therapy
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
33.3%
10/30 • Number of events 16 • Up to 2 years after completion of therapy
|
|
Vascular disorders
Thromboembolic event
|
10.0%
3/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
6.7%
2/30 • Number of events 3 • Up to 2 years after completion of therapy
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • Number of events 8 • Up to 2 years after completion of therapy
|
|
Investigations
Weight gain
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
2/30 • Number of events 2 • Up to 2 years after completion of therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place