18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.
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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.
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Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.
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Assess the time to progression for patients receiving resections and biopsies only.
TERTIARY OBJECTIVES:
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Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.
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Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Procedure: Biopsy
Undergo image-guided biopsy
Other Names:
Procedure: Computed Tomography
Undergo 18F-DOPA-PET/CT
Other Names:
Procedure: Diffusion Weighted Imaging
Undergo DTI
Other Names:
Drug: Fluorine F 18 Fluorodopa
Undergo 18F-DOPA-PET/CT
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Perfusion Magnetic Resonance Imaging
Undergo pMRI
Other Names:
Procedure: Positron Emission Tomography
Undergo 18F-DOPA-PET/CT
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo stereotactic craniotomy
|
Outcome Measures
Primary Outcome Measures
- Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N [Up to 5 years]
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.
Secondary Outcome Measures
- Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI [Up to 5 years]
Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes.
- Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue [Up to 5 years]
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.
- MRI contrast enhancement values [Up to 5 years]
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.
- 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 [Up to 5 years]
Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients.
Other Outcome Measures
- Accurate identification of the highest grade/highest density disease [Up to 5 years]
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 [Up to 5 years]
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 [Up to 5 years]
Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
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Planned craniotomy and resection or biopsy
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Willing to sign release of information for any radiation and/or follow-up records
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Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent
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Ability to provide tissue for mandatory correlative research component
Exclusion Criteria:
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Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
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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
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Any of the following:
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Pregnant women
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Nursing women
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Men or women of childbearing potential who are unwilling to employ adequate contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nadia Laack, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC1373
- NCI-2013-02373
- MC1373
- P30CA015083