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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01165632
First received: July 14, 2010
Last updated: November 12, 2013
Last verified: November 2013
  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:
  • 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 ]
    Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.

  • 18F- FDOPA-PET metabolic imaging information [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.

  • With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.

  • 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Primary Completion Date: July 2015 (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:

  • Age ≥18 years.
  • 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
  • Patients with eGFR < 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.

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
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: NCT01165632

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Nadia N. Laack, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
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: November 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 28, 2014