18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Adult Anaplastic (Malignant) Meningioma
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Choroid Plexus Neoplasm
Adult Diffuse Astrocytoma
Adult Giant Cell Glioblastoma
Adult Grade I Meningioma
Adult Grade II Meningioma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Papillary Meningioma
Adult Pilocytic Astrocytoma
Adult Pineal Gland Astrocytoma
Adult Primary Melanocytic Lesion of Meninges
Adult Subependymal Giant Cell Astrocytoma
Childhood Cerebellar Anaplastic Astrocytoma
Childhood Cerebellar Astrocytoma
Childhood Cerebral Anaplastic Astrocytoma
Childhood Cerebral Astrocytoma
Childhood Choroid Plexus Neoplasm
Childhood Grade I Meningioma
Childhood Grade II Meningioma
Childhood Grade III Meningioma
Childhood Infratentorial Ependymoma
Childhood Mixed Glioma
Childhood Supratentorial Ependymoma
Malignant Adult Intracranial Hemangiopericytoma
Newly Diagnosed Childhood Ependymoma
Recurrent Adult Brain Neoplasm
Recurrent Childhood Anaplastic Astrocytoma
Recurrent Childhood Anaplastic Oligoastrocytoma
Recurrent Childhood Anaplastic Oligodendroglioma
Recurrent Childhood Brain Stem Glioma
Recurrent Childhood Cerebellar Astrocytoma
Recurrent Childhood Cerebral Astrocytoma
Recurrent Childhood Diffuse Astrocytoma
Recurrent Childhood Ependymoma
Recurrent Childhood Fibrillary Astrocytoma
Recurrent Childhood Gemistocytic Astrocytoma
Recurrent Childhood Giant Cell Glioblastoma
Recurrent Childhood Glioblastoma
Recurrent Childhood Gliomatosis Cerebri
Recurrent Childhood Gliosarcoma
Recurrent Childhood Medulloblastoma
Recurrent Childhood Oligoastrocytoma
Recurrent Childhood Oligodendroglioma
Recurrent Childhood Pilocytic Astrocytoma
Recurrent Childhood Pilomyxoid Astrocytoma
Recurrent Childhood Pineoblastoma
Recurrent Childhood Pleomorphic Xanthoastrocytoma
Recurrent Childhood Protoplasmic Astrocytoma
Recurrent Childhood Subependymal Giant Cell Astrocytoma
Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
Recurrent Childhood Visual Pathway Glioma
Untreated Childhood Anaplastic Astrocytoma
Untreated Childhood Anaplastic Oligoastrocytoma
Untreated Childhood Anaplastic Oligodendroglioma
Untreated Childhood Brain Stem Glioma
Untreated Childhood Diffuse Astrocytoma
Untreated Childhood Fibrillary Astrocytoma
Untreated Childhood Gemistocytic Astrocytoma
Untreated Childhood Giant Cell Glioblastoma
Untreated Childhood Glioblastoma
Untreated Childhood Gliomatosis Cerebri
Untreated Childhood Gliosarcoma
Untreated Childhood Medulloblastoma
Untreated Childhood Oligoastrocytoma
Untreated Childhood Oligodendroglioma
Untreated Childhood Pilocytic Astrocytoma
Untreated Childhood Pilomyxoid Astrocytoma
Untreated Childhood Pineoblastoma
Untreated Childhood Pleomorphic Xanthoastrocytoma
Untreated Childhood Protoplasmic Astrocytoma
Untreated Childhood Subependymal Giant Cell Astrocytoma
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
Untreated Childhood Visual Pathway Glioma
Drug: Fluorine F 18 Fluorodopa
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Procedure: Diffusion Weighted Imaging
Procedure: Perfusion Magnetic Resonance Imaging
Procedure: Therapeutic Conventional Surgery
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas|
- Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]To determine the optimal PET threshold for distinguishing HGG from LGG brain tissue, receiver operating characteristic (ROC) analysis and the Youden's index (sum of the sensitivity and specificity - 1) will be used. The Youden's index will be calculated for each possible T/N threshold. The final ROC area under the curve (AUC) value and confidence intervals will be estimated using ROC analysis methods for clustered continuous data as described by Obychowski.
- MRI contrast enhancement values [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.
- Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.
- Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients.
- Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes.
- Progression free survival [ Time Frame: The time from study entry to progression, assessed up to 5 years ] [ Designated as safety issue: No ]
- Accurate identification of the highest grade/highest density disease [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume from pMRI.
- Accurate identification of tumor extent [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as disease extent comparing 18F-DOPA PET and diffusion maps from DTI.
- Role of metabolic imaging in neurosurgical resection planning [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes.
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Diagnostic (18F-DOPA-PET)
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Drug: Fluorine F 18 Fluorodopa
Other Name: 18F-FDOPAProcedure: Positron Emission Tomography
Other Names:Procedure: Computed Tomography
Other Names:Procedure: Diffusion Weighted Imaging
Other Names:Procedure: Perfusion Magnetic Resonance Imaging
Other Name: PW-MRIProcedure: Therapeutic Conventional Surgery
Undergo stereotactic craniotomyProcedure: Biopsy
Undergo image-guided biopsy
Other Name: BxOther: Laboratory Biomarker Analysis
I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) for low grade gliomas (LGG).
I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.
II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.
III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.
IV. Assess the time to progression for patients receiving resections and biopsies only.
I. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.
II. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.
III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
After completion of study treatment, patients are followed up yearly for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020720
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Nadia N. Laack|
|Principal Investigator:||Nadia Laack||Mayo Clinic|