Feasibility of FMISO in Brain Tumors

• Status: Recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well ¹⁸F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University
• Treatments: Misonidazole

Criteria

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.

• Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired

• 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.