Spots Global Cancer Trial Database for Feasibility of FMISO in Brain Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Feasibility of FMISO in Brain Tumors

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

Study ID: NCT03649880

Conditions

Malignant Brain Neoplasm

Interventions

¹⁸F-Fluoromisonidazole

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Oxygen Therapy

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the feasibility of obtaining ¹⁸F- fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values \[T/B\]) and dynamic susceptibility contrast enhanced (DSC) \& diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors. II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial. SECONDARY OBJECTIVE: I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration. TERTIARY OBJECTIVE: I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments. OUTLINE: 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. After conclusion of the diagnostic tests, participants are followed for up to 5 years.