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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

Must not have

Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents

Sickle cell disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo PET, MRI, or certain contrast agent procedures.

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I have sickle cell disease.

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I have a history of difficult IV access.

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My kidney function is reduced, with a GFR less than 45 mL/min.

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I have a condition where extra oxygen could be harmful to me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MRI contrast enhancement

Macro-imaging level feasibility

Secondary study objectives

Technical feasibility of PET/MRI

Other study objectives

Tumor regions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Positron Emission Tomography

2011

Completed Phase 2

~2200