18F-DOPA-PET in Planning Surgery in Patients with Gliomas
This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.
Inclusion Criteria
- MRI findings compatible with newly diagnosed or recurrent 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
- Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent
- Ability to provide tissue for mandatory correlative research component
Exclusion Criteria
- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
- Unable to undergo an 18F-DOPA 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; NOTE: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form
- Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02020720.
PRIMARY OBJECTIVES:
I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).
SECONDARY OBJECTIVES:
I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.
II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.
III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.
IV. Assess the time to progression for patients receiving resections and biopsies only.
V. Determine the optimal PET threshold for distinguishing regions of high tumor cell density/true tumor recurrence from those of low tumor cell density/ treatment effect in patients previously diagnosed and treated for glioblastoma.
TERTIARY OBJECTIVES:
I. Compare histopathology and biopsy-specific biomarker correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade / highest density disease.
II. Compare histopathology and biopsy-specific biomarker correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.
III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.
IV. Compare FDOPA images reconstructed with both the first 10 minutes of data acquisition as well as for 20 minutes of data acquisition to assess whether there is a reduction in noise that impacts the ability of the nuclear medicine physicians to delineate the disease.
OUTLINE:
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
After completion of study treatment, patients are followed up yearly for 5 years.
Trial PhasePhase O
Trial Typediagnostic
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorNadia Nicole Laack
- Primary IDMC1373
- Secondary IDsNCI-2013-02373, 13-005102
- ClinicalTrials.gov IDNCT02020720