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

PRIMARY OBJECTIVES:

I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy
targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR)
image (or PET/computed tomography [CT]) information with historical controls.

SECONDARY OBJECTIVES:

I. Compare progression free survival at 12 months after radiation therapy targeting volumes
designed with both 18F-DOPA-PET and conventional MR image information with historical
controls.

II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy
treatment including areas of high 18F-DOPA-PET uptake (T/N > 2.0).

CORRELATIVE RESEARCH OBJECTIVES:

I. Compare radiotherapy (RT) treatment volumes defined by MR only with RT treatment volumes
defined with both PET and MR information for grade IV glioma patients.

II. Compare differences in RT volumes identified using biopsy-validated thresholds as highly
aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume (relCBV) from
perfusion MRI (pMRI) as well as differences in RT volumes identified using biopsy-validated
thresholds as tumor extent comparing 18F-DOPA uptake and diffusion maps from diffusion tensor
imaging (DTI) will be evaluated.

III. Evaluate quality of life after radiotherapy using European Organization for Research and
Treatment of Cancer (EORTC) questionnaires compared with historical controls from
Keim-Guibert et al.

IV. Compare differences in proton radiation planning utilizing radiobiologic
modeling/evaluation techniques performed at Mayo Clinic Rochester to linear energy transfer
distribution evaluation at Mayo Clinic Arizona.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI or PET/CT imaging scan.
Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding
weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning course 2, patients
receive standard of care temozolomide on days 1-5. Courses with temozolomide repeat every 28
days for up to 7 courses in the in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, and
then periodically for up to 5 years.

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
antidopaminergic, 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 70 or over, and at the
determination of the 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