Trials / Completed
CompletedNCT01165632
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
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | biopsy | Correlative studies |
| PROCEDURE | computed tomography | Undergo computed tomography |
| 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 |
| PROCEDURE | magnetic resonance imaging | Undergo magnetic resonance imaging |
| PROCEDURE | positron emission tomography | Undergo positron emission tomography |
| DRUG | fluorine F 18 fluorodopa | Given IV |
Timeline
- Start date
- 2010-07-26
- Primary completion
- 2013-11-05
- Completion
- 2019-07-26
- First posted
- 2010-07-20
- Last updated
- 2025-09-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01165632. Inclusion in this directory is not an endorsement.