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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA108961 | U.S. NIH Grant/Contract | View source | |
| R01CA178200 | U.S. NIH Grant/Contract | View source | |
| NCI-2013-02373 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1373 | Other Identifier | Mayo Clinic | |
| 13-005102 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.
PRIMARY OBJECTIVES:
I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-DOPA-PET) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo image-guided biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N | 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI | Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes. | Up to 5 years |
| Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Accurate identification of the highest grade/highest density disease | 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. | Up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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: 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, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Debra H. Brinkmann, Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| 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 18F-DOPA-PET/CT |
|
|
| Diffusion Weighted Imaging | Procedure | Undergo DTI |
|
|
| Fluorine F 18 Fluorodopa | Drug | Undergo 18F-DOPA-PET/CT |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Perfusion Magnetic Resonance Imaging | Procedure | Undergo pMRI |
|
|
| Positron Emission Tomography | Procedure | Undergo 18F-DOPA-PET/CT |
|
|
| Therapeutic Conventional Surgery | Procedure | Undergo stereotactic craniotomy |
|
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. |
| Up to 5 years |
| MRI contrast enhancement values | 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. | Up to 5 years |
| Progression free survival | The time from study entry to progression, assessed up to 5 years |
| Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade | Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients. | Up to 5 years |
| Accurate identification of tumor extent |
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. |
| Up to 5 years |
| Role of metabolic imaging in neurosurgical resection planning | Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes. | Up to 5 years |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| 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 |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| C043437 | fluorodopa F 18 |
| D009682 | Magnetic Resonance Spectroscopy |
| 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 |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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