Feasibility of FMISO in Brain Tumors

Conditions

• IDH Wild Type Glioblastoma

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
• Ferumoxytol — DRUG
  Given IV
• Gadolinium — DRUG
  Given IV

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. Two contrast agents called gadolinium and ferumoxytol are used during some of the MRI scans. A contrast agent is a liquid-like dye that is given intravenously (IV) to help imaging machines create pictures. The study drug, called 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

First listed

Aug 28, 2018

Start date

Jun 1, 2019

Status verified

Sep 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2030

Study Design

Enrollment

77 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Diagnostic (FMISO, PET/MRI or PET/CT)
  Participants receive FMISO and/or FE IV. Patients also undergo dynamic PET/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 may then receive FMISO and/or Fe IV and gadolinium IV and undergo PET/MRI scan, followed by an additional PET/MRI scan without FMISO and/or Fe and gadolinium the following day. These scans may repeat every 4 weeks up to 4 times. Supplemental oxygen may be administered to affect MRI signal change.

Primary Outcome Measure

Successful production of images [ Time Frame: Two days of diagnostic imaging ]

Locations (1)

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