GlioblastomaPhase 2NCT03347617
Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma
A Phase 2 study testing Ferumoxytol, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with Glioblastoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works in assessing response to pembrolizumab in patients with glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's response to pembrolizumab treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ferumoxytol, Laboratory Biomarker Analysis 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
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 23 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be willing and able to provide written informed consent/assent for the trial
- Have a life expectancy of at least 6 months
- Have a histologically confirmed diagnosis of:
- Newly diagnosed glioblastoma (World Health Organization [WHO] grade IV)
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 on stable or reducing dose of steroids for symptom management (not more than 8 mg of dexamethasone or equivalent per day) for 5 days prior to enrollment; change in glucocorticoid dose for any purpose other than to modulate symptoms from an adverse event; Note: The use of physiologic doses (e.g., prednisone 10 mg) of corticosteroids may be approved after consultation with Merck \& Co; use of prophylactic corticosteroids to avoid allergic reactions (e.g. IV contrast dye) is permitted
- At least 14 days from any major surgeries including brain biopsy before the start of study drug pembrolizumab
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- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases
- Albumin >= 2.5 mg/dL
- International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; male subjects should agree to use an adequate method of contraception, including but not limited to, abstinence from heterosexual activity starting with the first dose of study therapy through 120 days after the last dose of study therapy
- Subject is eligible for and agrees to receive standard of care radiation and temozolamide after biopsy or maximum safe surgical resection
Who cannot join
- Has a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) (HIV 1/2 antibodies) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (an exception to this is the use of steroids for brain edema and resulting symptom); subjects may receive a stable or reducing dose of steroids (up to 8 mg dexamethasone or equivalent for at least 5 days prior to signing consent) to prevent or manage cerebral edema; subjects requiring over 8mg of dexamethasone per day on or five days prior to signing consent are excluded)
- Has a known history of active TB (Bacillus tuberculosis)
- Hypersensitivity to pembrolizumab or ferumoxytol or any of their excipients
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
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- Has known history of, or any evidence of active, non-infectious pneumonitis
- Has an active infection requiring systemic therapy
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
- Has received a live vaccine within 30 days of planned start of study therapy; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
- Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
- Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
- Subjects who have a contraindication for 3T MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated
- Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
- Subject who have received ferumoxytol within 3 weeks of study entry
- Subjects with three or more drug allergies from separate drug classes
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Response Assessment to Pembrolizumab With Standard of Care Therapy in Glioblastoma Using Ferumoxytol Steady State Imaging- A Pilot Study
This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works in assessing response to pembrolizumab in patients with glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's response to pembrolizumab treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the sensitivity and specificity of relative cerebral blood volume (rCBV) measured by steady state MRI with ferumoxytol in identifying true versus (vs) pseudoprogression in patients with newly diagnosed glioblastoma multiforme (GBM) receiving pembrolizumab with standard of care chemo-radiation.
SECONDARY OBJECTIVES:
- Determine the safety and toxicity of pembrolizumab when used in combination with standard of care chemo radiation.
II. Determine the progression free survival (PFS), overall survival (OS), clinical response and duration of best response.
EXPLORATORY OBJECTIVES:
- Compare the immune response as determined by the volume, pattern and intensity of delayed (24 hour [hr]) ferumoxytol uptake between subjects who develop true vs pseudoprogression.
II. Investigate the serum immunological parameters (serum biomarker) and correlate clinical as well as radiological response with systemic immune response to pembrolizumab as measured by immunological panel.
III. Compare the changes in PDL-1 expression in the biopsy tissue before and after therapy at the time of progression and correlate PD-L1 expression with response rates and survival.
IV. Investigate the feasibility of measuring vascular volume fraction (VVF), vessel size index (VSI) and vessel density index (VDI) as surrogate for response (true vs pseudoprogression, as determined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and immune related response criteria [irRC]).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, and then every 6 months thereafter.
- Conditions
- Glioblastoma
- Being tested
- Ferumoxytol, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Pembrolizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo ferumoxytol MRI
PembrolizumabBiological
Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Ferumoxytol MRI, pembrolizumab) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression. Receives: Drug: Ferumoxytol; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of Identifying Pseudoprogression
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Measured: At suspected progression, up to two years.
Sensitivity of Identifying True Progression
The calculation of sensitivity is based on steady state rCBV (relative cerebral blood volume) at suspected progression. Cutoff point 1.75.
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Measured: At suspected progression, up to two years.
Secondary outcomes (5)
Progression Free Survival
Will be assessed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Until off study, up to 5 years.
Overall Survival
Will be assessed using the Kaplan-Meier product limit estimates.
Measured: Until off study, up to 5 years.
Duration of Best Response
Will be analyzed using the Kaplan-Meier product limit estimates. Response assessment was completed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Until off study, up to 5 years.
Disease Response
Disease response was assessed based on a modified version of the Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Until off study, up to 5 years.
Determine the Safety and Toxicity of Pembrolizumab When Used in Combination With Standard of Care Chemo Radiation.
Number of participants with adverse events possibly related or related to pembrolizumab in combination with standard of care. Will be analyzed using proportions and exact 95% confidence intervals.
Measured: 30 days after last dose of pembrolizumab, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start20 Dec 2017
- Primary completion31 Dec 2023
- Study completion23 Jun 2025
Why it stopped: Principal investigator transition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Muldoon, OHSU Knight Cancer Institute
- Investigators
- Leslie Muldoon, Ph.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347617
- Sponsor's protocol ID
- STUDY00016046
- Other IDs
- NCI-2017-02008, STUDY00016046, K08CA237809
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2017
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Assessment to Pembrolizumab With Standard of Care Therapy in Glioblastoma Using Ferumoxytol Steady State Imaging- A Pilot Study
- ClinicalTrials.gov ID
- NCT03347617
- Acronym / sponsor ID
- STUDY00016046
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator transition
- Enrolment
- 52 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works in assessing response to pembrolizumab in patients with glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's response to pembrolizumab treatment.
Detailed description
PRIMARY OBJECTIVE:
- Determine the sensitivity and specificity of relative cerebral blood volume (rCBV) measured by steady state MRI with ferumoxytol in identifying true versus (vs) pseudoprogression in patients with newly diagnosed glioblastoma multiforme (GBM) receiving pembrolizumab with standard of care chemo-radiation.
SECONDARY OBJECTIVES:
- Determine the safety and toxicity of pembrolizumab when used in combination with standard of care chemo radiation.
II. Determine the progression free survival (PFS), overall survival (OS), clinical response and duration of best response.
EXPLORATORY OBJECTIVES:
- Compare the immune response as determined by the volume, pattern and intensity of delayed (24 hour [hr]) ferumoxytol uptake between subjects who develop true vs pseudoprogression.
II. Investigate the serum immunological parameters (serum biomarker) and correlate clinical as well as radiological response with systemic immune response to pembrolizumab as measured by immunological panel.
III. Compare the changes in PDL-1 expression in the biopsy tissue before and after therapy at the time of progression and correlate PD-L1 expression with response rates and survival.
IV. Investigate the feasibility of measuring vascular volume fraction (VVF), vessel size index (VSI) and vessel density index (VDI) as surrogate for response (true vs pseudoprogression, as determined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and immune related response criteria [irRC]).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.
After completion of study treatment, patients are followed up at 30 days, every 12 weeks for up to 1 year, and then every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Ferumoxytol MRI, pembrolizumab) | Experimental | Drug: Ferumoxytol, Other: Laboratory Biomarker Analysis, Procedure: Magnetic Resonance Imaging, Biological: PembrolizumabPatients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Be willing and able to provide written informed consent/assent for the trial
- Have a life expectancy of at least 6 months
- Have a histologically confirmed diagnosis of:
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 on stable or reducing dose of steroids for symptom management (not more than 8 mg of dexamethasone or equivalent per day) for 5 days prior to enrollment; change in glucocorticoid dose for any purpose other than to modulate symptoms from an adverse event; Note: The use of physiologic doses (e.g., prednisone 10 mg) of corticosteroids may be approved after consultation with Merck \& Co; use of prophylactic corticosteroids to avoid allergic reactions (e.g. IV contrast dye) is permitted
- At least 14 days from any major surgeries including brain biopsy before the start of study drug pembrolizumab
Key exclusion criteria (19 listed)
- Has a diagnosis of immunodeficiency including human immunodeficiency virus (HIV) (HIV 1/2 antibodies) and is not on continuous daily immunosuppressive therapy within 7 days prior to the first dose of trial treatment; (an exception to this is the use of steroids for brain edema and resulting symptom); subjects may receive a stable or reducing dose of steroids (up to 8 mg dexamethasone or equivalent for at least 5 days prior to signing consent) to prevent or manage cerebral edema; subjects requiring over 8mg of dexamethasone per day on or five days prior to signing consent are excluded)
- Has a known history of active TB (Bacillus tuberculosis)
- Hypersensitivity to pembrolizumab or ferumoxytol or any of their excipients
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
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 |
|---|---|---|
| FerumoxytolAlso: Feraheme, Ferumoxytol Non-Stoichiometric MagnetiteGiven IV | Drug | Diagnostic (Ferumoxytol MRI, pembrolizumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (Ferumoxytol MRI, pembrolizumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo ferumoxytol MRI | Procedure or surgery | Diagnostic (Ferumoxytol MRI, pembrolizumab) |
| PembrolizumabAlso: Keytruda, Lambrolizumab, MK-3475, SCH 900475Given IV | Biological | Diagnostic (Ferumoxytol MRI, pembrolizumab) |
Primary outcome
Specificity of Identifying Pseudoprogression
Time frame: At suspected progression, up to two years.
Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
Sensitivity of Identifying True Progression
Time frame: At suspected progression, up to two years.
The calculation of sensitivity is based on steady state rCBV (relative cerebral blood volume) at suspected progression. Cutoff point 1.75. Sensitivity and specificity are measures for the diagnostic performance of rCBV (relative cerebral blood volume) to distinguish between pseudoprogression and true progression. Sensitivity measures how well Fe-SS-rCBV identifies those who have true progression, and specificity those who have psuedoprogression. Because rCBV is a continuous variable, the cutoff point for this analysis was 1.75.
5 secondary outcomes
Progression Free Survival
Time frame: Until off study, up to 5 years.
Overall Survival
Time frame: Until off study, up to 5 years.
Duration of Best Response
Time frame: Until off study, up to 5 years.
Disease Response
Time frame: Until off study, up to 5 years.
Determine the Safety and Toxicity of Pembrolizumab When Used in Combination With Standard of Care Chemo Radiation.
Time frame: 30 days after last dose of pembrolizumab, up to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Leslie Muldoon, Ph.D. 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 Ferumoxytol, Laboratory Biomarker Analysis and Magnetic Resonance Imaging in people with 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 18 inclusion and 19 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: stopped early, as of the sponsor's last update on 9 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of Identifying Pseudoprogression (time frame: At suspected progression, up to two years.). The study lists 2 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 9 Sep 2025.