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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

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ClinicalTrials.gov Identifier: NCT01165632
Recruitment Status : Active, not recruiting
First Posted : July 20, 2010
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

July 14, 2010
July 20, 2010
October 8, 2018
July 26, 2010
August 26, 2016   (Final data collection date for primary outcome measure)
  • 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [ Time Frame: Up to 2 years ]
    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 ]
    Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
  • Correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
  • Differences in sensitivity and specificity as assessed by McNemar's test
  • Comparison of radiotherapy target volume delineation with and without 18F-FDOPA-PET metabolic imaging information
  • Biopsy validation of 18F-FDOPA-PET uptake and biodistribution in brain tumors
Complete list of historical versions of study NCT01165632 on ClinicalTrials.gov Archive Site
  • 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 ]
    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 ]
    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 ]
    Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.
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
Not Provided
Not Provided
 
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
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

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

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.

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • 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
    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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
30
July 2019
August 26, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01165632
MC1078
NCI-2010-01607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-001904 ( Other Identifier: Mayo Clinic IRB )
MC1078 ( Other Identifier: Mayo Clinic Cancer Center )
Yes
Not Provided
Not Provided
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Nadia N. Laack, M.D. Mayo Clinic
Mayo Clinic
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP