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| ID | Type | Description | Link |
|---|---|---|---|
| MC167B | Other Identifier | Cancer Center Identifier | |
| NCI-2017-02479 | Other Identifier | NCI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DOPA PET | Experimental | Patients will receive 18FDOPA-PET for radiation treatment planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorine F 18 Fluorodopa | Drug | Contrast used in PET |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Progression-free Survival | measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria
Exclusion Criteria
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:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia N Laack | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
1 registered patient did not proceed to protocol treatment because they were deemed ineligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Participants With Progression-free Survival | measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls | Posted | Number | 95% Confidence Interval | Proportion of participants | up to 3 months |
|
|
up to 2 years from randomization
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)
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocrine disorders - Other, specify | Endocrine disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia N. Laack, MD, MS | Mayo Clinic | 507/284-2511 | Laack.Nadia@mayo.edu |
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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 | May 22, 2019 | Apr 5, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
| D050397 | Radiotherapy, Intensity-Modulated |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Intensity-Modulated Radiation Therapy | Radiation | 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 | Procedure | imaging test |
|
|
| 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) | up to 2 years |
| 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. | Baseline and 3 months |
| Re-operative Count | Count of patients that receive re-operation post re-irradiation | up to 2 years |
| 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'. | Baseline and 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Posted | Median | 95% Confidence Interval | years | 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 |
|
|
|
| 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) | Posted | Number | percentage of participants | up to 2 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. | All patients that entered a baseline and at 3 months. | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 3 months |
|
|
|
| Secondary | Re-operative Count | Count of patients that receive re-operation post re-irradiation | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
| 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'. | All treated patients that had available data at baseline and during end of treatment. | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 3 months |
|
|
|
| 15 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| 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 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Central nervous system necrosis | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Headache | 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 |
|
| Seizure | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D013057 |
| Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |