Actively Recruiting
Feasibility of FMISO in Brain Tumors
Led by OHSU Knight Cancer Institute · Updated on 2025-03-25
50
Participants Needed
1
Research Sites
556 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of FMISO in Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (greater than 18 years of age) 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.
You will not qualify if you...
- 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 m2 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.
- Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation (end-stage COPD, OSA on CPAP/Bi-PAP, etc).
- Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study.
- Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care).
- 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.
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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