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Virus Therapy
FMISO Imaging for Brain Cancer
Phase 2
Recruiting
Led By Ramon Barajas
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging
Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial uses FMISO to see how much oxygen is getting to brain tumors and whether PET/MRI can show this.
Who is the study for?
This trial is for adults over 18 with known or suspected brain tumors who can consent to the study. They should have a performance score indicating they're fairly active and able to care for themselves, and either planning or have had treatment for their tumor. Pregnant individuals, those with severe kidney issues, claustrophobia, certain allergies, or conditions where oxygen therapy could be harmful are excluded.Check my eligibility
What is being tested?
The trial tests how well FMISO works with PET/MRI scans in assessing malignant brain tumors by showing oxygen levels within the tumor. This may help understand the tumor's behavior better and improve imaging techniques.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of FMISO PET/MRI might include discomfort from lying still during scanning procedures, allergic reactions to contrast agents used in imaging (if any), and exposure to radiation from PET scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a brain lesion larger than 10 mL suspected to be cancer.
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I am over 18 and may have a brain tumor.
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I am mostly independent and can care for myself.
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I am planning to or have already received treatment for a brain tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRI contrast enhancement
Macro-imaging level feasibility
Secondary outcome measures
Technical feasibility of PET/MRI
Other outcome measures
Tumor regions
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (FMISO, PET/MRI or PET/CT)Experimental Treatment5 Interventions
Participants receive FMISO intravenously (IV). Participants 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 then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen Therapy
2021
N/A
~10
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,676 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,023 Total Patients Enrolled
Weill Cornell UniversityUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not sure if you are pregnant according to the guidelines of the Department of Radiology and AIRC.My legal representative has agreed to my participation in this study.I have a brain lesion larger than 10 mL suspected to be cancer.I cannot undergo PET, MRI, or certain contrast agent procedures.You are afraid of being in small or enclosed spaces.I have sickle cell disease.I do not have any serious illnesses that could affect my participation in the study.I have a history of difficult IV access.You weigh more than the maximum weight limit for the study equipment.I can join the study even if I can't use supplemental oxygen due to health reasons.I am over 18 and may have a brain tumor.I am mostly independent and can care for myself.You have metal objects or medical devices in your body that are not safe for MRI scans according to the Oregon Health & Science University guidelines.You have had allergic reactions to drugs similar to FMISO. It's very unlikely that you are allergic to nitroimidazoles.I am planning to or have already received treatment for a brain tumor.My kidney function is reduced, with a GFR less than 45 mL/min.I have a condition where extra oxygen could be harmful to me.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (FMISO, PET/MRI or PET/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants will be included in this research?
"That is accurate. The clinicaltrial.gov website has information suggesting that the study is still looking for 20 patients to enroll at 1 location."
Answered by AI
What other research projects have used Magnetic Resonance Imaging technology?
"There is 1 active clinical trial studying the effects of Magnetic Resonance Imaging. This research project has not yet reached Phase 3 and is based in Portland, Oregon."
Answered by AI
Has the FDA cleared Magnetic Resonance Imaging for use?
"While Phase 2 trials don't have data supporting efficacy, there is some safety data available which resulted in our team giving it a score of 2."
Answered by AI
Can more people join this clinical trial?
"That is accurate. The clinical trial, which began recruitment on June 1st 2019, as indicated by information found on clinicaltrials.gov, is still looking for 20 participants at a single location."
Answered by AI
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