Feasibility of FMISO in Brain Tumors

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT03649880
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Brain Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ¹⁸F-Fluoromisonidazole — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/MRI
  • Oxygen Therapy — PROCEDURE
    Receive supplemental oxygen

Study Details

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.

Key Dates

Start date
Jun 1, 2019
Status verified
Mar 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (FMISO, PET/MRI or PET/CT)
    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.

Primary Outcome Measure

Macro-imaging level feasibility [ Time Frame: One day of diagnostic imaging ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Ramon Barajas
[email protected]
503-494-3408
Ramon Barajas (PRINCIPAL_INVESTIGATOR)

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By research site
OHSU Knight Cancer Institute· Portland, OR

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