NCT03649880 Feasibility of FMISO in Brain Tumors
| NCT ID | NCT03649880 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Malignant Brain Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-06-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2019-06-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility 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.
Contact & Investigator
Ramon Barajas
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT03649880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Brain Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03649880 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03649880 currently recruiting?
Yes, NCT03649880 is actively recruiting participants. Visit ClinicalTrials.gov or contact OHSU Knight Cancer Institute to inquire about joining.
Where is the NCT03649880 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03649880 clinical trial?
NCT03649880 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Ramon Barajas at OHSU Knight Cancer Institute. The trial plans to enroll 50 participants.