Using FMISO PET/MRI to assess brain tumors
Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03649880 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients over 18 with known or suspected malignant brain tumors who can provide informed consent.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to PET or MRI will not benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor. * 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 lesion known or suspected to be neoplastic greater than 10 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. * Planning to undergo or previously received therapeutic intervention for the intracranial tumor. Exclusion Criteria: * Pregnant or breast feeding. * Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents. * Claustrophobia. * Weight 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). * Sickle cell disease. * Reduced renal function, as determined by glomerular filtration rate (GFR) \< 45 mL/min/1.73 m\^2 based on a serum creatinine level obtained per OHSU Department of Radiology and Advanced Imaging Research Center (AIRC) clinical criteria. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely. * 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 COPD, OSA on CPAP/Bi-PAP, etc). * Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study. * 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 this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Ramon Barajas — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.