IDH Wild Type GlioblastomaPhase 2NCT03649880
Feasibility of FMISO in Brain Tumors
A Phase 2 study testing ¹⁸F-Fluoromisonidazole, Computed Tomography and Magnetic Resonance Imaging in people with IDH Wild Type Glioblastoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH Wild Type Glioblastoma
- What is being tested?
- ¹⁸F-Fluoromisonidazole, Computed Tomography and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Ramon Barajas, 503-494-3408, RADResearch@ohsu.edu
Ramon Barajas
About this study
Official title: Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of obtaining 18F-fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values [T/B]) and dynamic susceptibility contrast enhanced (DSC), diffusion-weighted imaging (DWI), \& segregation \& extravascular localization of ferumoxytol imaging (SELFI) MRI measures in patients with intracranial brain tumors.
II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.
III. Determine if SELFI hypoxic fraction are imaging biomarkers of glioblastoma neuroinflammation.
SECONDARY OBJECTIVES:
- Determine the feasibility of baseline and follow-up ferumoxytol (Fe)-enhanced FMISO PET and MR imaging co-registration.
II. Assess diagnostic performance of imaging metrics to identify failed therapy at earlier imaging timepoints before presumed progression.
III. Determine the reliability of the pre-therapy FMISO PET imaging metrics as assessed by baseline "test" and "retest experiments.
IV. Compare the diagnostic performance of SELFI hypoxic fraction to Modified Response Assessment in Neuro-Oncology (mRANO) criteria.
- Determine the sensitivity and specificity of SELFI hypoxic fraction for the diagnosis of neuroinflammation and recurrent disease.
VI. Assess progression free survival. VII. Assess overall survival. VIII. Determine change in imaging metrics from post-therapy and disease progression in differentiating neuroinflammation from recurrent disease.
IX. Determine optimal SELFI hypoxic fraction imaging parameters. X. Correlate SELFI hypoxic fraction with innate immune phenotype and hypoxia expression.
TERTIARY OBJECTIVE:
- Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.
OUTLINE:
Participants receive FMISO and/or FE IV. Patients also undergo dynamic PET/computed tomography (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.
After conclusion of the diagnostic tests, participants are followed for up to 5 years.
- Conditions
- IDH Wild Type Glioblastoma
- Being tested
- ¹⁸F-Fluoromisonidazole, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography, Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¹⁸F-FluoromisonidazoleDrug
Also called ¹⁸F-MISO, ¹⁸F-Misonidazole, FMISO
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo PET/MRI or PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/MRI
Oxygen TherapyProcedure or surgery
Also called supplemental oxygen therapy
Receive supplemental oxygen
FerumoxytolDrug
Also called Feraheme, Ferumoxytol, ferumoxytol, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
GadoliniumDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (FMISO, PET/MRI or PET/CT) | Experimental | 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. Receives: Drug: ¹⁸F-Fluoromisonidazole; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Oxygen Therapy; Drug: Ferumoxytol; Drug: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful production of images
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], diffusion-weighted imaging [DWI], and segregation \& extravascular localization of ferumoxytol imaging [SELFI] 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 estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.
Measured: Two days of diagnostic imaging
SELFI and hypoxic fraction, and T1 ferumoxytol Fe/gadolinium (Gd) log mismatch ratio in patients receiving immunotherapy
Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and area under the receiver operating curve (AUROC). Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.
Measured: 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
Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and AUROC. Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.
Measured: Two days of diagnostic imaging at time of suspected progression
Secondary outcomes (14)
Successful co-registration (Yes vs. No)
The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (< 10mm versus [vs.] > 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided.
Measured: Baseline to the start of long-term follow-up (up to 5 years)
T/B value and hypoxic tumor volume
Tumor-to-background ratio (TBR) is calculated by dividing the tumor SUV by the mean SUV of the background region, using either voxelwise values or summary measures such as SUVmean. To define hypoxic volume, a threshold-based approach is applied in which all tumor voxels with FMISO uptake above a predetermined TBR cutoff are classified as hypoxic; the hypoxic volume is then calculated as the total volume of these above-threshold voxels. Hypoxic volume is measured in mm3.
Measured: Time Frame: Baseline to the start of long-term follow-up (up to 5 years)
Generation of SELFI Metric
Will assess generation of whole brain SELFI MRI data set. Generation of SELFI MRI: YES/NO.
Measured: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
SELFI diagnostic performance of imaging metrics
SELFI metric will be assessed to identify failed therapy at each imaging timepoint. Assessing Failed Therapy: Area Under the Curve for each metric at each time point to diagnose disease progression
Measured: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Generation of Hypoxic Fraction Metric
Will assess generation of hypoxic fraction data set. Generation of hypoxic fraction: MRI YES/NO.
Measured: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Hypoxic Fraction Diagnostic performance of imaging metric
Hypoxic Fraction metric will be assessed to identify failed therapy at each imaging timepoint. Assessing Failed Therapy: Area Under the Curve for each metric at each time point to diagnose disease progression.
Measured: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Hypoxic fraction
Will determine the reproducibility of the pre-therapy FMISO PET imaging metrics as assessed by baseline "test" and "retest experiments. Reproducibility of hypoxic fraction between baseline "test" and "retest experiments will be evaluated by intra-class correlation coefficients (ICC).
Measured: Retest will be scheduled within 7 days after the initial PET imaging examination, Baseline, year 1-4]
SELFI, hypoxic fraction and Modified Response Assessment in Neuro-Oncology (mRANO) criteria
Sensitivity, specificity and AUROC will be used to determine the diagnostic performance of imaging biomarkers (SELFI and hypoxic fraction, change in SELFI and hypoxic fraction between fraction between post-radiation therapy and suspected disease progression) and mRANO to differentiate progression from neuroinflammation (pseudoprogresion). Optimal cutoff points for SELFI and hypoxic fraction will be identified. Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. McNemar's test will be used to compare sensitivity and specificity between imaging biomarkers and mRANO. Comparison of diagnostic performance with Gd MRI may also be explored.
Measured: Year 1-5 at suspected disease progression
SELFI and hypoxic fraction
Will determine the sensitivity and specificity of SELFI hypoxic fraction for the diagnosis of neuroinflammation and recurrent disease. Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. McNemar's test will be used to compare sensitivity and specificity between imaging biomarkers and mRANO. Comparison of diagnostic performance with Gd MRI may also be explored.
Measured: Year 1-5 at suspected disease progression
Progression free survival (PFS)
Will be analyzed using the Kaplan-Meier product limit methods for all patients, taking censoring into account. A Cox regression model will be used to explore the association between imaging biomarkers and PFS while adjusting for patient characteristics.
Measured: Date of diagnosis to date of progression, death or end of study, assessed up to 5 years
Overall survival (OS)
Will be analyzed using the Kaplan-Meier product limit methods for all patients, taking censoring into account. A Cox regression model will be used to explore the association between imaging biomarkers and OS while adjusting for patient characteristics.
Measured: Date of diagnosis to date of progression, death or end of study, assessed up to 5 years
Change in SELFI and hypoxic fraction
Difference of SELFI or hypoxic fraction between post-radiation therapy and suspected disease progression
Measured: From post-therapy to disease progression/pseudoprogression, year 1-5
SELFI
Will determine optimal SELFI imaging parameters. Outcome Measure: Optimal SELFI imaging echo time (TE) and repetition time (TR). Description: The optimal SELFI imaging parameters will be defined as the echo time (TE) and repetition time (TR) combination that demonstrates the highest correlation coefficient between SELFI and macrophage cellular density measured in tumor tissue samples. Unit of Measure: Milliseconds (ms).
Measured: Baseline at year 1-3
SELFI and hypoxic fraction
Will assess correlation of SELFI hypoxic fraction with innate immune phenotype and hypoxia expression. Since innate immune phenotype is a binary variable (M1, or M2), differences in imaging metrics between M1 and M2 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. Hypoxia expression will be measured by an ordinal variable (0,1,2,3,4) based on CA-9 expression, and correlation between SELFI/hypoxic fraction and hypoxia expression will be evaluated by Spearman's rank correlation coefficient.
Measured: Year 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Jun 2019
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDH Wild Type GlioblastomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Barajas, OHSU Knight Cancer Institute
- Investigators
- Ramon Barajas, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649880
- Sponsor's protocol ID
- STUDY00016043
- Other IDs
- R37CA288577, NCI-2018-01479, STUDY00016043
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors
- ClinicalTrials.gov ID
- NCT03649880
- Acronym / sponsor ID
- STUDY00016043
- Conditions
- IDH Wild Type Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of obtaining 18F-fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values [T/B]) and dynamic susceptibility contrast enhanced (DSC), diffusion-weighted imaging (DWI), \& segregation \& extravascular localization of ferumoxytol imaging (SELFI) MRI measures in patients with intracranial brain tumors.
II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.
III. Determine if SELFI hypoxic fraction are imaging biomarkers of glioblastoma neuroinflammation.
SECONDARY OBJECTIVES:
- Determine the feasibility of baseline and follow-up ferumoxytol (Fe)-enhanced FMISO PET and MR imaging co-registration.
II. Assess diagnostic performance of imaging metrics to identify failed therapy at earlier imaging timepoints before presumed progression.
III. Determine the reliability of the pre-therapy FMISO PET imaging metrics as assessed by baseline "test" and "retest experiments.
IV. Compare the diagnostic performance of SELFI hypoxic fraction to Modified Response Assessment in Neuro-Oncology (mRANO) criteria.
- Determine the sensitivity and specificity of SELFI hypoxic fraction for the diagnosis of neuroinflammation and recurrent disease.
VI. Assess progression free survival. VII. Assess overall survival. VIII. Determine change in imaging metrics from post-therapy and disease progression in differentiating neuroinflammation from recurrent disease.
IX. Determine optimal SELFI hypoxic fraction imaging parameters. X. Correlate SELFI hypoxic fraction with innate immune phenotype and hypoxia expression.
TERTIARY OBJECTIVE:
- Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.
OUTLINE:
Participants receive FMISO and/or FE IV. Patients also undergo dynamic PET/computed tomography (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.
After conclusion of the diagnostic tests, participants are followed for up to 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (FMISO, PET/MRI or PET/CT) | Experimental | Drug: ¹⁸F-Fluoromisonidazole, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Procedure: Oxygen Therapy, Drug: Ferumoxytol, Drug: GadoliniumParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ¹⁸F-FluoromisonidazoleAlso: ¹⁸F-MISO, ¹⁸F-Misonidazole, FMISOGiven IV | Drug | Diagnostic (FMISO, PET/MRI or PET/CT) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (FMISO, PET/MRI or PET/CT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo PET/MRI or PET/CT | Procedure or surgery | Diagnostic (FMISO, PET/MRI or PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/MRI | Procedure or surgery | Diagnostic (FMISO, PET/MRI or PET/CT) |
| Oxygen TherapyAlso: supplemental oxygen therapyReceive supplemental oxygen | Procedure or surgery | Diagnostic (FMISO, PET/MRI or PET/CT) |
| FerumoxytolAlso: Feraheme, Ferumoxytol, ferumoxytol, FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE, Ferumoxytol Non-Stoichiometric MagnetiteGiven IV | Drug | Diagnostic (FMISO, PET/MRI or PET/CT) |
| GadoliniumGiven IV | Drug | Diagnostic (FMISO, PET/MRI or PET/CT) |
Primary outcome
Successful production of images
Time frame: Two days 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], diffusion-weighted imaging [DWI], and segregation \& extravascular localization of ferumoxytol imaging [SELFI] 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 estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.
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
Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and area under the receiver operating curve (AUROC). Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.
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
Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and AUROC. Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.
14 secondary outcomes
Successful co-registration (Yes vs. No)
Time frame: Baseline to the start of long-term follow-up (up to 5 years)
T/B value and hypoxic tumor volume
Time frame: Time Frame: Baseline to the start of long-term follow-up (up to 5 years)
Generation of SELFI Metric
Time frame: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
SELFI diagnostic performance of imaging metrics
Time frame: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Generation of Hypoxic Fraction Metric
Time frame: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Hypoxic Fraction Diagnostic performance of imaging metric
Time frame: Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
Hypoxic fraction
Time frame: Retest will be scheduled within 7 days after the initial PET imaging examination, Baseline, year 1-4]
SELFI, hypoxic fraction and Modified Response Assessment in Neuro-Oncology (mRANO) criteria
Time frame: Year 1-5 at suspected disease progression
SELFI and hypoxic fraction
Time frame: Year 1-5 at suspected disease progression
Progression free survival (PFS)
Time frame: Date of diagnosis to date of progression, death or end of study, assessed up to 5 years
Overall survival (OS)
Time frame: Date of diagnosis to date of progression, death or end of study, assessed up to 5 years
Change in SELFI and hypoxic fraction
Time frame: From post-therapy to disease progression/pseudoprogression, year 1-5
SELFI
Time frame: Baseline at year 1-3
SELFI and hypoxic fraction
Time frame: Year 1-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Advanced Solid Tumor
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A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Glioblastoma
Not yet recruitingEarly Phase 1
Biomarker-guided RAdiation-deferring Treatment in Younger GBM Patients - Pilot Study
IDH Wildtype Glioblastoma, Glioblastoma (GBM)
RecruitingPhase 2
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
Glioblastoma, IDH-Wildtype, Progressive Astrocytoma, IDH-Mutant, Grade 4
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramon Barajas principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ¹⁸F-Fluoromisonidazole, Computed Tomography and Magnetic Resonance Imaging in people with IDH Wild Type Glioblastoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful production of images (time frame: Two days of diagnostic imaging). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.