18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy
Condition: Glioblastoma; Malignant Glioma
MeSH terms: Glioblastoma; Glioma
Intervention: Computed Tomography; Fluorodopa F 18; Magnetic Resonance Imaging; Positron Emission Tomography; Proton Beam Radiation Therapy; Quality-of-Life Assessment; Questionnaire Administration; Temozolomide
Intervention description: Undergo PET/CT; Given IV; Undergo PET/MRI; Undergo PET/CT or PET/MRI; Receive proton beam RT; Ancillary studies; Ancillary studies; Drug
Intervention MeSH terms: Temozolomide; Levodopa; Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic
      resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly
      diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of
      proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells
      during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor
      cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation
      therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of
      radiation therapy over a shorter period of time and may kill more tumor cells and have fewer
      side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the
      radiation doctor with information on tumor tissue versus normal, healthy tissue and may help
      the doctor more accurately plan the radiation treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed newly diagnosed grade IV malignant glioma

          -  Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester

          -  Willing to sign release of information for any radiation and/or follow-up records

          -  Provide informed written consent

          -  Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72 m^2

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

        Exclusion Criteria:

          -  Patients diagnosed with grades I-III glioma

          -  Currently on Avastin at time of treatment

          -  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

          -  Pregnant women, nursing women, or men or women of childbearing potential who are
             unwilling to employ adequate contraception.

               -  NOTE: All women enrolled in this study will be age 65 or over, and at the
                  determination of the principal investigator (PI), will not be of childbearing
                  potential. If the radiology department requires a pregnancy test before
                  administering the 18FDOPA injection, they may perform one per their standard of
                  care