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 October 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01165632
First received: July 14, 2010
Last updated: October 16, 2012
Last verified: October 2012
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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 2013 (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:
Procedure: magnetic resonance imaging
Undergo magnetic resonance imaging
Other Names:
Procedure: positron emission tomography
Undergo positron emission tomography
Other Names:
Drug: fluorine F 18 fluorodopa
Given IV
Other Names:
|
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
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: | October 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Oligodendroglioma Astrocytoma Ependymoma Glioblastoma Glioma 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 May 23, 2013