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18F-DOPA-PET in Planning Surgery in Patients With Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nadia N. Laack, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02020720
First received: December 19, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention
Acoustic Schwannoma
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Meningioma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Choroid Plexus Tumor
Adult Craniopharyngioma
Adult Diffuse Astrocytoma
Adult Ependymoblastoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Grade I Meningioma
Adult Grade II Meningioma
Adult Medulloblastoma
Adult Meningeal Hemangiopericytoma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Oligodendroglioma
Adult Papillary Meningioma
Adult Pilocytic Astrocytoma
Adult Pineal Gland Astrocytoma
Adult Pineoblastoma
Adult Pineocytoma
Adult Subependymal Giant Cell Astrocytoma
Adult Subependymoma
Childhood Choroid Plexus Tumor
Childhood Craniopharyngioma
Childhood Ependymoblastoma
Childhood Grade I Meningioma
Childhood Grade II Meningioma
Childhood Grade III Meningioma
Childhood High-grade Cerebellar Astrocytoma
Childhood High-grade Cerebral Astrocytoma
Childhood Infratentorial Ependymoma
Childhood Low-grade Cerebellar Astrocytoma
Childhood Low-grade Cerebral Astrocytoma
Childhood Medulloepithelioma
Childhood Mixed Glioma
Childhood Supratentorial Ependymoma
Meningeal Melanocytoma
Newly Diagnosed Childhood Ependymoma
Recurrent Adult Brain Tumor
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 and Hypothalamic Glioma
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 and Hypothalamic Glioma
Untreated Childhood Visual Pathway Glioma
Drug: fluorine F 18 fluorodopa
Procedure: positron emission tomography
Procedure: computed tomography
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: perfusion-weighted magnetic resonance imaging
Procedure: therapeutic conventional surgery
Procedure: biopsy
Other: laboratory biomarker analysis

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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, 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 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 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.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 and 3 days after resection. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Drug: fluorine F 18 fluorodopa
Undergo 18F-DOPA-PET/CT
Other Names:
  • (18)F-FDOPA
  • 18F-6- L-fluorodopa
  • 18F-DOPA
  • 18F-FDOPA
Procedure: positron emission tomography
Undergo 18F-DOPA-PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo 18F-DOPA-PET/CT
Other Name: tomography, computed
Procedure: diffusion-weighted magnetic resonance imaging
Undergo DTI
Other Name: diffusion-weighted MRI
Procedure: perfusion-weighted magnetic resonance imaging
Undergo pMRI
Other Name: PW-MRI
Procedure: therapeutic conventional surgery
Undergo stereotactic craniotomy
Procedure: biopsy
Undergo image-guided biopsy
Other Name: biopsies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

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).

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 and 3 days after resection. Patients then undergo stereotactic craniotomy or image-guided biopsy.

After completion of study treatment, patients are followed up yearly for 5 years.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
  • Planned craniotomy and resection or biopsy
  • Willing to sign release of information for any radiation and/or follow-up records
  • Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent
  • Ability to provide tissue for mandatory correlative research component
  • Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72m^2

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)
  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020720

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nadia N. Laack    507-284-2511    laack.nadia@mayo.edu   
Principal Investigator: Nadia N. Laack         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Nadia Laack Mayo Clinic
  More Information

No publications provided

Responsible Party: Nadia N. Laack, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02020720     History of Changes
Other Study ID Numbers: MC1373, NCI-2013-02373, MC1373, P30CA015083
Study First Received: December 19, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Craniopharyngioma
Adamantinoma
Ependymoma
Glioblastoma
Glioma
Hemangiopericytoma
Medulloblastoma
Meningioma
Neurilemmoma
Neuroma, Acoustic
Oligodendroglioma
Pinealoma
Choroid Plexus Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma, Subependymal
Gliosarcoma
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases

ClinicalTrials.gov processed this record on July 28, 2014