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Feasibility of FMISO in Brain Tumors

This study is looking at how well a special imaging agent called ¹⁸F-fluoromisonidazole (FMISO) works with PET/MRI scans to assess malignant (cancerous) brain tumors. FMISO helps doctors see the oxygen levels in a tumor, which can affect how the tumor grows and responds to treatment. PET/MRI combines two types of scans to create detailed images of the brain and how it's functioning. The study aims to see if FMISO PET/MRI can accurately show the oxygen levels within brain tumors. You may be eligible if you are an adult (18 years or older) with a known or suspected brain tumor. The study will measure how practical it is to get these images and if MRI contrast enhancement can help tell the difference between tumor growth and treatment effects over up to 5 years. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive FMISO intravenously (into a vein) and undergo PET/CT or PET/MRI scans multiple times. You may also receive supplemental oxygen. These diagnostic tests will be followed by a retest examination within 7 days.
Compensation
Not stated in the trial record.
Follow-up
After the diagnostic tests, participants will be followed for up to 5 years.

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NCT03649880

Feasibility of FMISO in Brain Tumors

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
OHSU Knight Cancer Institute
~50 participants
Updated 2025-03-25 on ClinicalTrials.gov
What's tested:¹⁸F-FluoromisonidazoleComputed TomographyMagnetic Resonance ImagingPositron Emission TomographyOxygen Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Macro-imaging level feasibility
Measured over One day of diagnostic imaging
+1 more outcome measured

Conditions

Malignant Brain Neoplasm

Explore related trials

Malignant Brain Neoplasm

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Ramon Barajas · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Ramon Barajas
[email protected]
503-494-3408
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.

What this trial measures

  • Macro-imaging level feasibilityOne day of diagnostic imaging

    Assessed as a factor of generating quantitative positron emission tomography (PET)/magnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood \[T/B\] level, hypoxic volume, dynamic susceptibility contrast enhanced \[DSC\], and diffusion-weighted imaging \[DWI\] values, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. Following completion of cohort enrollment, the generation of each quantitative PET/MRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The successful generation of PET/MRI metrics in 85% of the initial cohort successfully imaged will need to be achieved for the imaging modality to be deemed feasible for this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.

  • MRI contrast enhancementUp to 5 years

    Measured by Response assessment in neuro-oncology criteria sum product diameter assessment. The primary outcomes for this aim are enhancement mismatch ratio and hypoxic volume. Differences in imaging metrics will be evaluated using two sample t-test. If normal assumption is not satisfied, data transformation, or 95% confidence intervals based on bootstrapping method will be used. Exploratory analysis will assess diagnostic performance of imaging metrics (mismatch ratio and hypoxic volume) to identify pseudoprogression at earlier imaging dates.