Glioma
Conditions
Brief summary
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
Interventions
Contrast used in PET
RADIATIONIntensity-Modulated Radiation Therapy
Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor
PROCEDUREPositron Emission Tomography
imaging test
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or equal to 18 years * ECOG PS \< or equal to 3 * Histologically confirmed or radiographic evidence of recurrent/progressive glioma. * History of radiation therapy to the brain for prior diagnosis of glioma * Planned radiation treatments at Mayo Clinic Rochester * Provide informed written consent * Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136 (blood draw optional) * Willing to return to enrolling institution for follow-up during Active Monitoring Phase of the study.
Exclusion criteria
* More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to re-irradiation target volumes * Unable to undergo MRI scans with contrast * Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking anti dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists.) Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). If a patient is on any of these drugs, list which ones on the On-Study form. -Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Progression-free Survival | up to 3 months | measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years | Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization |
| Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities | up to 2 years | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm) |
| Quality of Life Brief Fatigue Index (BFI) Change From Baseline | Baseline and 3 months | Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine. |
| Re-operative Count | up to 2 years | Count of patients that receive re-operation post re-irradiation |
| Quality of Life MDASI-BT Change From Baseline | Baseline and 3 months | QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'. |
Countries
United States
Participant flow
Pre-assignment details
1 registered patient did not proceed to protocol treatment because they were deemed ineligible.
Participants by arm
| Arm | Count |
|---|---|
| 18F-DOPA PET Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. Intensity-Modulated Radiation Therapy: Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Positron Emission Tomography: imaging test | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | 18F-DOPA PET |
|---|---|
| Age, Continuous | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Proportion of Participants With Progression-free Survival
measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls
Time frame: up to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-DOPA PET | Proportion of Participants With Progression-free Survival | 0.85 Proportion of participants |
Secondary
Overall Survival
Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization
Time frame: From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 18F-DOPA PET | Overall Survival | 3.7 years |
Secondary
Quality of Life Brief Fatigue Index (BFI) Change From Baseline
Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.
Time frame: Baseline and 3 months
Population: All patients that entered a baseline and at 3 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 18F-DOPA PET | Quality of Life Brief Fatigue Index (BFI) Change From Baseline | 0.28 score on a scale |
Secondary
Quality of Life MDASI-BT Change From Baseline
QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.
Time frame: Baseline and 3 months
Population: All treated patients that had available data at baseline and during end of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 18F-DOPA PET | Quality of Life MDASI-BT Change From Baseline | -0.15 score on a scale |
Secondary
Re-operative Count
Count of patients that receive re-operation post re-irradiation
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 18F-DOPA PET | Re-operative Count | 0 Participants |
Secondary
Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Time frame: up to 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-DOPA PET | Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities | 40 percentage of participants |