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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01607 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10-001904 | Other Identifier | Mayo Clinic IRB | |
| MC1078 | Other Identifier | Mayo Clinic Cancer Center |
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RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
PRIMARY OBJECTIVES:
I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE:
Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
After completion of study treatment, patients are followed up every year for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy | Procedure | Correlative studies |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies | Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies. | Up to 2 years |
| 18F- FDOPA-PET metabolic imaging information | Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies | Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia N. Laack, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| computed tomography | Procedure | Undergo computed tomography |
|
|
| therapeutic conventional surgery | Procedure | Undergo stereotactic craniotomy |
|
| radiation therapy treatment planning/simulation | Radiation | Undergo radiation therapy treatment planning/simulation |
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| radiation therapy | Radiation | Undergo radiation therapy |
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| magnetic resonance imaging | Procedure | Undergo magnetic resonance imaging |
|
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| positron emission tomography | Procedure | Undergo positron emission tomography |
|
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| fluorine F 18 fluorodopa | Drug | Given IV |
|
|
| With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information | Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning. | 2 Years |
| 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies | Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies. | 2 years |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| D018315 | Glioma, Subependymal |
| 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 |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| C043437 | fluorodopa F 18 |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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