Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using FMISO PET/MRI to assess brain tumors

Official title: Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors

Run by OHSU Knight Cancer Institute · NCT03649880 · Data updated 2026-11-12

This study is testing a new imaging method using a special dye and scans to see if it can help doctors understand the oxygen levels in brain tumors and how they grow.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment77 (estimated)
SponsorOHSU Knight Cancer Institute
Academic / other
Drugs / interventionsradiation, immunotherapy
Locations1 site (Portland, Oregon)
StatusRecruiting
StartedJune 1, 2019
Main results expectedJanuary 31, 2029
Study endsJanuary 31, 2030
Registry record updatedSeptember 18, 2026
Trial IDNCT03649880 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adult patients over 18 with known or suspected malignant brain tumors who can provide informed consent.

Probably not a fit

Patients who are pregnant, breastfeeding, or have contraindications to PET or MRI will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of ¹⁸F-fluoromisonidazole (FMISO) combined with PET and MRI imaging to assess malignant brain tumors. The study aims to determine the feasibility of obtaining imaging metrics that reflect tumor oxygen levels, which may influence tumor behavior. Participants will receive FMISO intravenously and undergo a series of imaging sessions to gather data on tumor hypoxia and progression. The trial also seeks to establish the reproducibility of these imaging metrics through retest examinations.

Why it matters

Potential benefit: If successful, this approach could enhance the understanding of tumor oxygenation and improve treatment strategies for patients with malignant brain tumors.

How similar studies have gone: While the use of FMISO in imaging is established, this specific combination of FMISO with PET/MRI in brain tumors is a novel approach that has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • OHSU Knight Cancer Institute
    Portland, Oregon, United States
    Recruiting

Study contacts

  • Principal investigator: Ramon Barajas — OHSU Knight Cancer Institute

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.