Recruiting
Phase 2

FMISO

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT03649880

Conditions

IDH Wild Type Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

¹⁸F-Fluoromisonidazole

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Oxygen Therapy

Study Details

Brief 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. Two contrast agents called gadolinium and ferumoxytol are used during some of the MRI scans. A contrast agent is a liquid-like dye that is given intravenously (IV) to help imaging machines create pictures. The study drug, called 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

IDH Wild Type Glioblastoma

Study ID

NCT03649880

Start date

Jun 1, 2019

Status verified date

Sep, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (FMISO, PET/MRI or PET/CT)

Participants receive FMISO and/or FE IV. Patients also undergo dynamic PET/CT or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants may then receive FMISO and/or Fe IV and gadolinium IV and undergo PET/MRI scan, followed by an additional PET/MRI scan without FMISO and/or Fe and gadolinium the following day. These scans may repeat every 4 weeks up to 4 times. Supplemental oxygen may be administered to affect MRI signal change.

Interventions

¹⁸F-Fluoromisonidazole

Given IV

Computed Tomography

Undergo PET/CT

Magnetic Resonance Imaging

Undergo PET/MRI or PET/CT

Positron Emission Tomography

Undergo PET/MRI

Oxygen Therapy

Receive supplemental oxygen

Ferumoxytol

Given IV

Gadolinium

Given IV

Primary outcome measure

  • Successful production of images [ Time Frame: Two days of diagnostic imaging ]
  • SELFI and hypoxic fraction, and T1 ferumoxytol Fe/gadolinium (Gd) log mismatch ratio in patients receiving immunotherapy [ Time Frame: Two days of diagnostic imaging at time of suspected progression ]
  • SELFI and hypoxic fraction, and T1 ferumoxytol Fe/gadolinium (Gd) log mismatch ratio in all patients [ Time Frame: Two days of diagnostic imaging at time of suspected progression ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ramon Barajas

503-494-3408RADResearch@ohsu.edu

Principal Investigator:

Ramon Barajas

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.