Actively Recruiting
Feasibility of ⁸F-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors
Led by OHSU Knight Cancer Institute · Updated on 2025-03-25
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ⁸F-fluoromisonidazole (FMISO) combined with PET/MRI imaging to study malignant brain tumors. This phase II trial aims to determine how well FMISO PET and MRI measures can be obtained, and whether MRI contrast-enhancement and hypoxic volume can distinguish between true tumor progression and immunotherapy-related pseudoprogression in glioblastoma patients. The study also assesses the reproducibility of FMISO PET imaging and the feasibility of image co-registration over time. Participants receive FMISO through an intravenous injection and undergo dynamic PET/CT or PET/MRI imaging for about 120 minutes starting shortly before the injection, followed by a static scan approximately 90 minutes post-injection lasting 20 to 40 minutes. A retest scan is performed within 7 days, and up to two additional scans may be done at intervals of at least 4 weeks. Supplemental oxygen may be given to enhance MRI signals. After these diagnostic scans, participants are monitored for up to five years. During the study, participants undergo multiple imaging sessions including PET, CT, and MRI scans to assess tumor oxygen levels and brain function. Researchers measure imaging features such as hypoxic volume and MRI contrast enhancement. Safety and technical feasibility are evaluated throughout the study and long-term follow-up occurs for up to five years. This comprehensive imaging approach helps researchers understand tumor behavior and treatment response in patients with malignant brain tumors.
CONDITIONS
Brief Title
Feasibility of FMISO in Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor
- Able to provide informed written consent or have an acceptable surrogate provide consent
- Legally authorized representative-signed informed consent and assent for decisionally impaired subjects
- Intracranial lesion known or suspected to be neoplastic greater than 10 mL by MRI
- Karnofsky performance score greater than 60 or ECOG less than 3
- Planning to undergo or previously received treatment for the intracranial tumor
You will not qualify if you...
- Pregnant or breastfeeding
- Contraindications to PET, MRI, FMISO, or intravenous gadolinium contrast agents
- Claustrophobia
- Weight exceeding imaging equipment limits
- Metallic foreign body or implants not verified as MRI safe
- Sickle cell disease
- Reduced kidney function (GFR less than 45 mL/min/1.73 m²)
- History of allergic reactions to FMISO-like compounds
- Uncertain pregnancy status
- Conditions making supplemental oxygen harmful (e.g., severe lung disease)
- Poor peripheral intravenous access
- Serious illnesses such as uncontrolled infection, other malignancy, uncontrolled diabetes type II, or psychiatric/social issues affecting study participation
- Co-existing conditions increasing risk or limiting compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on scan schedule
Participants receive FMISO intravenously and undergo dynamic PET/CT or PET/MRI scans over 120 minutes starting 1 minute before injection, followed by static PET/CT or PET/MRI scans approximately 90 minutes after injection. A retest examination is performed within 7 days. Participants may undergo up to 2 additional PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be given to affect MRI signal.
1 initial scan visit, 1 retest visit within 7 days, and up to 2 additional scan visits spaced at least 4 weeks apart
Duration - Up to 5 years
After the diagnostic imaging tests, participants are followed to assess MRI contrast enhancement and other imaging outcomes for up to 5 years.
Periodic follow-up visits during the monitoring period
Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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