Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors

Who is this study for? Adult patients with Malignant Brain Neoplasms
What treatments are being studied? 18F-Fluoromisonidazole
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Time Frame
Start Date: 2019-06-01
Estimated Completion Date: 2030-01-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, Weill Cornell University, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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