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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


N/A
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

Outcome Description:

Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Nadia N. Laack, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

MC1078

NCT ID:

NCT01165632

Start Date:

July 2010

Completion Date:

Related Keywords:

  • 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
  • Astrocytoma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma
  • Glioma, Subependymal
  • Gliosarcoma

Name

Location
Mayo Clinic Rochester, Minnesota  55905