Trial Outcomes & Findings for 18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy (NCT NCT01991977)
NCT ID: NCT01991977
Last Updated: 2025-10-20
Results Overview
The proportion of Grade IV MGMT un-methylated patients that experience confirmed-progression-free survival at 6 months (CPFS6). Progression is defined by any of the following: * ≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose. * Failure to return for evaluation due to death or deteriorating condition * Clear progression of non-measurable disease
COMPLETED
PHASE2
91 participants
Time from registration to the confirmed disease progression, assessed at 6 months
2025-10-20
Participant Flow
Participant milestones
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
Received PET Tracer
|
84
|
|
Overall Study
Received IMRT Treatment
|
79
|
|
Overall Study
Evaluable for the Primary Outcome
|
39
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Overall Study
Withdrew prior to receiving treatment
|
7
|
|
Overall Study
Withdrew after start of treatment
|
5
|
Baseline Characteristics
18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy
Baseline characteristics by cohort
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=79 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 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
|
|
Histologic grade of primary tumor
Grade 3
|
4 Participants
n=5 Participants
|
|
Histologic grade of primary tumor
Grade 4
|
75 Participants
n=5 Participants
|
|
MGMT
Methylated
|
25 Participants
n=5 Participants
|
|
MGMT
Un-Methylated
|
39 Participants
n=5 Participants
|
|
MGMT
NA
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from registration to the confirmed disease progression, assessed at 6 monthsPopulation: All Grade IV MGMT un-methylated patients meeting eligibility criteria who have signed a consent form and who have begun treatment with 18F-DOPA PET image-guided dose escalation RT will be evaluable for the endpoint.
The proportion of Grade IV MGMT un-methylated patients that experience confirmed-progression-free survival at 6 months (CPFS6). Progression is defined by any of the following: * ≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose. * Failure to return for evaluation due to death or deteriorating condition * Clear progression of non-measurable disease
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=39 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)
|
0.795 proportion of participants
Interval 0.631 to 0.901
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All eligible patients were included in analysis.
The median survival time and 95%CI will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=63 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Overall Survival
Unmethylated patients
|
16.0 months
Interval 13.8 to 21.1
|
|
Overall Survival
Methylated patients
|
35.5 months
Interval 25.5 to 74.4
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients eligible for analysis were included
The median progression-free survival time and 95%CI will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=63 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Progression Free Survival
Unmethylated patients
|
8.7 months
Interval 7.6 to 11.0
|
|
Progression Free Survival
Methylated patients
|
10.7 months
Interval 8.9 to 16.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients that completed an assessment at baseline and at the first MRI assessment were included in analysis
The MDASI-BT consists of 28 questions. Twenty-two questions are related to severity of symptoms over the last 24 hours and are answered on a scale of 0-10 where 0=not present and10=as bad as you can imagine. The remaining 6 questions are related to how symptoms have interfered with daily life over the past 24 hours and are answered on a scale of 0-10 where 0=did not interfere and 10=interfered completely. Higher scores indicate greater severity of symptoms and greater interference with daily life. Analysis will include median change percent from baseline.
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=61 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Quality of Life Evaluated With the M. D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Questionnaire
|
-0.167 percent change
Interval -6.3 to 8.17
|
SECONDARY outcome
Timeframe: Up to 5 yearsAdverse events graded using Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=75 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Number of Patients Experiencing Grade 3+ Treatment-related Toxicities
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsLate treatment-related toxicities will be assessed using the Radiation Therapy Oncology Group (RTOG) European Organization for Research and the Treatment of Cancer (EORTC) toxicity criteria.
Outcome measures
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=63 Participants
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Number of Patients Experiencing Grade 4+ Late Treatment-related Toxicities
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe concordance correlation coefficient will be used to measure agreement between volumes generated with each method, as well as to evaluate inter-observer variability, where variability associated with magnetic resonance imaging will serve as the standard for comparison.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe concordance correlation coefficient will be used to measure agreement between volumes generated with each method, as well as to evaluate inter-observer variability, where variability associated with magnetic resonance imaging will serve as the standard for comparison.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPaired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information. The analysis of volumes from 72 grade IV patients will have 90% power to detect differences in volumes with an effect size of 0.39 using a paired t-test with a 0.05 two-sided significance level. Alternate metrics for comparison will also be assessed, including spatial overlap, distanc
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsChi-square tests of proportions will be used to test for differences in the proportions of patients with central, in-field, marginal, or distant failures between the patients on this study and historical controls.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsCompared by identifying the recurrence volume with each modality and correlating with identification of aggressive disease in the pre-radiation therapy planning images.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPaired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsPaired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information. The analysis of volumes from 72 grade IV patients will have 90% power to detect differences in volumes with an effect size of 0.39 using a paired t-test with a 0.05 two-sided significance level. Alternate metrics for comparison will also be assessed, including spatial overlap, distan
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsThe progression identification timing will be compared by calculating the percentage of time each modality was earlier than conventional magnetic resonance imaging. With a sample size of 72, if the observed percentage earlier than conventional magnetic resonance imaging is 30% for either modality, a two-sided 95% confidence interval for a single proportion using the large sample normal approximation will be +/- 10.6%. Progression identification timing will also be compared using Kaplan-Meier methods and paired t-tests to determine if differences exist between the modalities.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsProgression identification timing will be compared using Kaplan-Meier methods and paired t-tests to determine if differences exist between the modalities. An exploratory analysis of diffusion tensor imaging for detecting invasive non-enhancing tumor recurrence will also be performed.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
Serious adverse events
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=84 participants at risk
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
General disorders
Fatigue
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Diagnostic (PET, pMRI, DTI, IMRT, Temozolomide)
n=84 participants at risk
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.2%
1/84 • Number of events 2 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.2%
1/84 • Number of events 2 • Up to 5 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
3.6%
3/84 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Optic nerve disorder
|
1.2%
1/84 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Anal fistula
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
6.0%
5/84 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
General disorders
Edema limbs
|
2.4%
2/84 • Number of events 5 • Up to 5 years
|
|
General disorders
Fatigue
|
96.4%
81/84 • Number of events 329 • Up to 5 years
|
|
General disorders
Fever
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
General disorders
Gait disturbance
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
General disorders
Localized edema
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
General disorders
Malaise
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
General disorders
Pain
|
3.6%
3/84 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Peripheral nerve infection
|
2.4%
2/84 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
4.8%
4/84 • Number of events 4 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
3.6%
3/84 • Number of events 3 • Up to 5 years
|
|
Investigations
Weight loss
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
2/84 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.1%
6/84 • Number of events 7 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.8%
4/84 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Ataxia
|
3.6%
3/84 • Number of events 5 • Up to 5 years
|
|
Nervous system disorders
Central nervous system necrosis
|
33.3%
28/84 • Number of events 81 • Up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
10.7%
9/84 • Number of events 14 • Up to 5 years
|
|
Nervous system disorders
Concentration impairment
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Dysarthria
|
4.8%
4/84 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Dysphasia
|
6.0%
5/84 • Number of events 5 • Up to 5 years
|
|
Nervous system disorders
Facial muscle weakness
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
14.3%
12/84 • Number of events 14 • Up to 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
6.0%
5/84 • Number of events 7 • Up to 5 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
7.1%
6/84 • Number of events 9 • Up to 5 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.8%
4/84 • Number of events 5 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
11.9%
10/84 • Number of events 19 • Up to 5 years
|
|
Nervous system disorders
Neuralgia
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Presyncope
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
10.7%
9/84 • Number of events 11 • Up to 5 years
|
|
Nervous system disorders
Somnolence
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Stroke
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/84 • Number of events 2 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Psychiatric disorders
Suicidal ideation
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.4%
18/84 • Number of events 21 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.6%
3/84 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
1.2%
1/84 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
2.4%
2/84 • Number of events 2 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place