Radioactive tracer lights up Oxygen-Starved brain tumors
NCT ID NCT03649880
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing a radioactive tracer called FMISO with PET/MRI scans to map oxygen levels inside malignant brain tumors. Adults with a suspected glioma receive the tracer by IV, then undergo brain scans that combine PET and MRI, sometimes with contrast dyes. The study checks whether these scans can reliably produce images of tumor oxygen and help distinguish tumor growth from inflammation after immunotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-fluoromisonidazole, a radioactive tracer given by IV that highlights low-oxygen areas in tumors
- What this could lead to
- If it works, doctors could use FMISO PET/MRI to see which parts of a brain tumor lack oxygen and to tell true tumor growth apart from inflammation after immunotherapy, which may guide treatment decisions.
- What could go wrong
- This is a phase II feasibility study in 77 people with suspected glioma, so it tests whether clear images can be produced, not whether patients live longer. The tracer and scanning methods may fail to give consistent results, and findings may not apply to other tumor types or centers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 77 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients (18 years of age and older) with a clinically suspected glioma * 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 disease greater than 5 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. * Either has previously received therapeutic intervention for an intracranial tumor or is eligible for and agreeable to receiving standard of care stupp protocol radiation and temozolomide after biopsy or maximum safe surgical resection * Life expectancy of at least 6 months * Female subject of childbearing potential will be asked for possibility of pregnancy. If unsure of pregnancy status, then a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study drug (FMISO). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Adequate organ function as demonstrated by a chart review of platelets, renal, hepatic, and coagulation. We will follow the Department of Diagnostic Radiology clinical policy for assessing renal function prior to injecting gadolinium-based contrast. If there is a history of poor kidney function, a point of care serum creatinine test may be performed to ensure adequate kidney function prior to FMISO administration. If there is a history of any other poor organ function, we will not administer Ferumoxytol, but the subject may receive all other study interventions Exclusion Criteria: * Pregnant or breastfeeding. * Contraindication to PET, MRI, FMISO, ferumoxytol, or intravenous gadolinium based contrast agents. * Claustrophobia is not controlled with medical therapy * Weight is 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). * Subjects with family history of or known iron overload (genetic hemochromatosis). * Subject who have received ferumoxytol within 3 weeks of study entry and require another ferumoxytol administration. * Subjects with three or more drug allergies from separate drug classes. * History of hypersensitivity allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely. * Sickle cell disease. * History of hypersensitivity allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol or gadolinium MRI contrast * 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 chronic obstructive pulmonary disease \[COPD\], obstructive sleep apnea \[OSA\] on continuous positive airway pressure \[CPAP\]/biphasic positive airway pressure \[Bi-PAP\], etc). * 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Locations
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OHSU Knight Cancer Institute
RECRUITINGPortland, Oregon, 97239, United States
Contact Email: •••••@•••••
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