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

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
This study is currently recruiting participants.
Verified April 2012 by Mayo Clinic

First Received on July 14, 2010.  
Last Updated on April 18, 2012  
History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01165632
  Purpose

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

Condition Intervention
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Diffuse Astrocytoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Oligodendroglioma
Adult Pilocytic Astrocytoma
Adult Pineal Gland Astrocytoma
Adult Subependymal Giant Cell Astrocytoma
Adult Subependymoma
Procedure: biopsy
Procedure: computed tomography
Procedure: therapeutic conventional surgery
Radiation: radiation therapy treatment planning/simulation
Radiation: radiation therapy
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Drug: fluorine F 18 fluorodopa

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

  • Correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Differences in sensitivity and specificity as assessed by McNemar’s test [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Comparison of radiotherapy target volume delineation with and without 18F-FDOPA-PET metabolic imaging information [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Biopsy validation of 18F-FDOPA-PET uptake and biodistribution in brain tumors [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall and progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Arm I

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.
Procedure: biopsy

Correlative studies
Other Name: biopsies

Procedure: computed tomography

Undergo computed tomography
Other Name: tomography, computed

Procedure: therapeutic conventional surgery

Undergo stereotactic craniotomy

Radiation: radiation therapy treatment planning/simulation

Undergo radiation therapy treatment planning/simulation

Radiation: radiation therapy

Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

Procedure: magnetic resonance imaging

Undergo magnetic resonance imaging
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Procedure: positron emission tomography

Undergo positron emission tomography
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed

Drug: fluorine F 18 fluorodopa

Given IV
Other Names:
  • (18)F-FDOPA
  • 18F-6- L-fluorodopa
  • 18F-DOPA
  • 18F-FDOPA

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MRI findings compatible with newly diagnosed 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
  • Negative pregnancy test done =< 48 hours of injection of study drug, for women of childbearing potential only
  • Provide informed written consent

Exclusion Criteria:

  • Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
  • Unable to undergo an 18F-FDOPA 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)
  • Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165632

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office     507-538-7623        
Principal Investigator: Nadia N. Laack, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Nadia N. Laack, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Nadia Nicole Laack, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01165632    
History of Changes
Other Study ID Numbers: MC1078, NCI-2010-01607, 10-001904, MC1078
Study First Received: July 14, 2010
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:

Astrocytoma
Ependymoma
Glioblastoma
Glioma
Oligodendroglioma
Glioma, Subependymal
Gliosarcoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Fluorides
Dihydroxyphenylalanine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2012

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