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

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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

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

OHSU Knight Cancer Institute, Portland, Oregon, United States

Contact Details

Name: Ramon Barajas

Affiliation: OHSU Knight Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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