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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02242 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1374 | Other Identifier | Mayo Clinic | |
| 13-005106 | Other Identifier | Mayo Clinic Institutional Review Board |
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This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES:
I. Compare confirmed-progression free survival at 6 months for grade IV MGMT unmethylated glioma patients after radiation therapy targeting volumes designed with both 18F-DOPA PET and conventional magnetic resonance (MR) image information with historical controls from Mayo Clinic Rochester patients, including those treated on North Central Cancer Treatment Group (NCCTG) clinical trials.
SECONDARY OBJECTIVES:
I. Compare progression free survival at 12 months for grade III patients after radiation therapy targeting volumes designed with both 18F-DOPA PET and conventional MR image information with historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
II. Compare patient overall survival after radiation therapy targeting volumes designed with both 18F-DOPA PET and conventional MR image information with historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
III. Evaluate quality of life after radiotherapy treatment targeting dose escalated volumes defined to include high 18F-DOPA PET uptake.
IV. Determine acute and late effect toxicity after radiotherapy treatment targeting dose escalated volumes defined to include high 18F-DOPA PET uptake.
V. Compare confirmed-progression free survival at 12 months for grade IV MGMT methylated patients after radiation therapy targeting volumes designed with both 18F-DOPA PET and conventional MR image information with historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
VI. Compare confirmed-progression free survival in grade IV MGMT un-methylated patients with similar historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
VII. Compare confirmed-progression free survival in grade IV MGMT methylated patients with similar historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
TERTIARY OBJECTIVES:
I. Compare radiation therapy (RT) treatment volumes defined by MR only with RT treatment volumes defined with both PET and MR information for grade IV glioma patients.
II. Compare timing of accurate identification of progression defined by 18F-DOPA PET, perfusion magnetic resonance imaging (pMRI) and conventional MRI for grade IV glioma patients.
III. Compare patterns of failure after radiation therapy targeting volumes defined with target volumes designed to with both 18F-DOPA PET and conventional MR image information with patterns of failure for historical controls from Mayo Clinic Rochester patients, including those on NCCTG clinical trials.
IV. Compare RT treatment volumes defined by MR only with RT treatment volumes defined with both PET and MR information for grade III glioma patients.
V. Evaluate intra- and inter-observer variability with vs. without the addition of 18F-DOPA PET uptake for radiotherapy target volume delineation.
VI. Compare timing of accurate identification of progression defined by 18F-DOPA PET, pMRI and conventional MRI for grade III glioma patients.
VII. Compare predictive capabilities of 18F-DOPA PET, pMRI and diffusion tensor imaging (DTI) for localization of recurrences for patients treated with 18F-DOPA PET-guided RT dose escalation.
OUTLINE:
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 intensity-modulated radiation therapy (IMRT) over 30 fractions and receive temozolomide.
After completion of study treatment, patients are followed up periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (PET, pMRI, DTI, IMRT, temozolomide) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | Undergo DTI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6) | 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:
| Time from registration to the confirmed disease progression, assessed at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The median survival time and 95%CI will be estimated using the method of Kaplan-Meier. | Up to 5 years |
| Progression Free Survival | The median progression-free survival time and 95%CI will be estimated using the method of Kaplan-Meier. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation | The 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. |
Inclusion Criteria:
Exclusion Criteria:
Patients diagnosed with anaplastic oligodendroglioma
Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
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 consist of: amoxapine, amphetamine, benztropine, bupropion, 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:
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| Name | Affiliation | Role |
|---|---|---|
| Debra H. Brinkmann, Ph.,D. | Mayo Clinic in Rochester | Principal Investigator |
| Nadia N. Laack, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33771703 | Derived | Laack NN, Pafundi D, Anderson SK, Kaufmann T, Lowe V, Hunt C, Vogen D, Yan E, Sarkaria J, Brown P, Kizilbash S, Uhm J, Ruff M, Zakhary M, Zhang Y, Seaberg M, Wan Chan Tseung HS, Kabat B, Kemp B, Brinkmann D. Initial Results of a Phase 2 Trial of 18F-DOPA PET-Guided Dose-Escalated Radiation Therapy for Glioblastoma. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1383-1395. doi: 10.1016/j.ijrobp.2021.03.032. Epub 2021 Mar 23. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2018 |
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| Fluorine F 18 Fluorodopa | Drug | Undergo 18F-DOPA-PET |
|
|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
|
| Perfusion Magnetic Resonance Imaging | Procedure | Undergo pMRI |
|
|
| Positron Emission Tomography | Procedure | Undergo 18F-DOPA-PET |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Temozolomide | Drug | Receive temozolomide |
|
|
| Up to 5 years |
| Quality of Life Evaluated With the M. D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Questionnaire | 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. | Up to 5 years |
| Number of Patients Experiencing Grade 3+ Treatment-related Toxicities | Adverse events graded using Common Terminology Criteria for Adverse Events version 4.0 | Up to 5 years |
| Number of Patients Experiencing Grade 4+ Late Treatment-related Toxicities | Late 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. | Up to 5 years |
| Up to 5 years |
| Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation | The 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. | Up to 5 years |
| Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning | Paired 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 | Up to 5 years |
| Patterns of Failure After Radiation Therapy Targeting Volumes by 18F-DOPA Positron Emission Tomography and Conventional Magnetic Resonance Imaging | Chi-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. | Up to 5 years |
| Predictive Capabilities of 18F-DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging, and Diffusion Tensor Imaging for Localization of Recurrences | Compared by identifying the recurrence volume with each modality and correlating with identification of aggressive disease in the pre-radiation therapy planning images. | Up to 5 years |
| Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only and Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade III Glioma Patients | Paired 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. | Up to 5 years |
| Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only or Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade IV Glioma Patients | Paired 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 | Up to 5 years |
| Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade IV Glioma Patients | The 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. | Up to 5 years |
| Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade III Glioma Patients | Progression 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. | Up to 5 years |
| Received PET Tracer | Received the experimental FDOPA PET tracer; evaluable for AEs |
|
| Received IMRT Treatment | Received IMRT treatment based on the FDOPA imaging results |
|
| Evaluable for the Primary Outcome | Grade IV MGMT un-methylated glioma patients after radiation therapy |
|
| COMPLETED | Received standard of care CT simulation and received treatment |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Histologic grade of primary tumor | Anaplastic astrocytoma (grade-III glioma) is a mid-grade tumor & diffusely infiltrating neoplasm demonstrating focal or dispersed anaplasia cells & an increased growth index compared with grade I & II astrocytoma. Pathological diagnosis is based on appearance of cells (nuclear atypia) & growth rate (mitotic activity). Glioblastoma (Grade-IV glioma) is the highest grade glioma tumor & is the most malignant form of astrocytoma. The histologic features include: presence of necrosis (dead cells), increase of abnormal growth of blood vessels around the tumor, tumors are always rapidly growing. | Count of Participants | Participants |
| |||||||||||||||||
| MGMT | MGMT : O6-methylguanine-DNA methyltransferase methylation status PET : Positron-emission tomography pMRI : parallel magnetic resonance imaging DTI : Diffusion Tensor Imaging IMRT : Intensity-modulated radiation therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6) | 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:
| 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Time from registration to the confirmed disease progression, assessed at 6 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival | The median survival time and 95%CI will be estimated using the method of Kaplan-Meier. | All eligible patients were included in analysis. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | The median progression-free survival time and 95%CI will be estimated using the method of Kaplan-Meier. | All patients eligible for analysis were included | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life Evaluated With the M. D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Questionnaire | 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. | Patients that completed an assessment at baseline and at the first MRI assessment were included in analysis | Posted | Median | Full Range | percent change | Up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients Experiencing Grade 3+ Treatment-related Toxicities | Adverse events graded using Common Terminology Criteria for Adverse Events version 4.0 | Posted | Count of Participants | Participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Experiencing Grade 4+ Late Treatment-related Toxicities | Late 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. | Posted | Count of Participants | Participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation | The 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. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation | The 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. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning | Paired 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 | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Patterns of Failure After Radiation Therapy Targeting Volumes by 18F-DOPA Positron Emission Tomography and Conventional Magnetic Resonance Imaging | Chi-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. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Predictive Capabilities of 18F-DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging, and Diffusion Tensor Imaging for Localization of Recurrences | Compared by identifying the recurrence volume with each modality and correlating with identification of aggressive disease in the pre-radiation therapy planning images. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only and Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade III Glioma Patients | Paired 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. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only or Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade IV Glioma Patients | Paired 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 | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade IV Glioma Patients | The 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. | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade III Glioma Patients | Progression 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. | Not Posted | Up to 5 years | Participants |
Up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 56 | 84 | 3 | 84 | 82 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Ear and labyrinth disorders - Oth spec | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | MedDRA 12 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Oth spec | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
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| Weight loss | Investigations | MedDRA 12 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Musculoskeletal, conn tissue - Oth spec | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Central nervous system necrosis | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Concentration impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Dysphasia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Facial muscle weakness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Intracranial hemorrhage | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness left-sided | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness right-sided | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Nervous system disorders - Oth spec | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| Psychiatric disorders - Other, specify | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia N. Laack, MD | Mayo Clinic | 507/284-2511 | Laack.Nadia@mayo.edu |
| Mar 17, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2018 | Jul 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
| D050397 | Radiotherapy, Intensity-Modulated |
| D009682 | Magnetic Resonance Spectroscopy |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| NA |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|