Feasibility of FMISO in Brain Tumors

PRIMARY OBJECTIVES:

I. Determine the feasibility of obtaining FMISO PET (hypoxic volume and tumor to blood
background values [T/B]) and dynamic susceptibility contrast enhanced (DSC) &
diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors.

SECONDARY OBJECTIVES:

I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging
co-registration.

TERTIARY OBJECTIVES:

I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by
baseline "test" and "retest" experiments.

OUTLINE:

Participants receive ¹⁸F-fluoromisonidazole intravenously (IV) and 1.5 - 2 hours later
undergo PET/CT or PET/MRI over 20-40 minutes and a retest examination within 7 days.
Participants may undergo 2 more PET/MRI scans no sooner than every 4 weeks.

After conclusion of the diagnostic tests, participants are followed for up to 5 years.

Inclusion Criteria:

- Adult patients with a known or suspected intracranial tumor.

- Able to provide informed written consent and/or acceptable surrogate capable of
providing consent on the patient?s behalf.

- Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed
by T2/fluid attenuated inversion recovery (FLAIR) MR imaging.

- Karnofsky performance score > 60 or Eastern Cooperative Oncology Group (ECOG) < 3 as
assessed by referring clinician.

- Planning to undergo or previously received therapeutic intervention for the
intracranial tumor.

Exclusion Criteria:

- Pregnant or breast feeding.

- Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents.

- Claustrophobia.

- Weight greater than modality maximum capacity.

- Presence of metallic foreign body or implanted medical devices in body not
documented as MRI safe according to the Oregon Health & Science University (OHSU)
Department of Radiology guidelines (including but not limited to cardiac
pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves
with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel
implants).

- Sickle cell disease.

- Reduced renal function, as determined by glomerular filtration rate (GFR) < 45
mL/min/1.73 m^2 based on a serum creatinine level obtained per OHSU Department of
Radiology and Advanced Imaging Research Center (AIRC) clinical criteria.

- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly
unlikely.

- Unsure of pregnancy status as assessed by Department of Radiology and AIRC
guidelines.

- Presence of any other co-existing condition that, in the judgment of the principal
investigator, might increase the risk to the subject.

- Poor peripheral intravenous access evaluated by patient history.

- Presence of other serious systemic illnesses, including: uncontrolled infection, other
uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social
situations which might impact the endpoint of the study or limit compliance with study
requirements.