CLEVAR

Title: A clinical enabling study of bone-marrow vascular leak measured by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) in healthy subjects and patients with Acute Myeloid Leukaemia (AML)

Disease site: AML

Status: Open to recruitment

Trial Design: Previous studies have shown that patients with acute myeloid leukaemia (AML) have damage to blood vessels that is associated with the bone marrow. There is increased vascular leak and hypoxia. This hypoxia then results in an increase in levels of nitric oxide (NO). These high NO levels, with the increased vascular leak, may make treatment less effective. It has therefore been suggested that giving AML patients a drug that blocks NO, alongside chemotherapy, may reduce vascular leak and provide a more effective form of treatment. Recent results suggest that if these vascular leaks could be detected earlier, it could be very useful when deciding appropriate treatment for these patients. Magnetic resonance imaging (MRI) is a non-invasive way to measure vascular function in patients. It is used to view the anatomy and the physiology of the body using magnetic fields and the properties of certain elements contained in the body.

This study is designed to assess whether MRI is an effective way of measuring vascular leak in the bone marrow of participants with AML before and after chemotherapy. This will hopefully provide information that could be used in the design of future research studies using an NO inhibitor to reduce vascular leak in AML. In order for this study to provide accurate measurements of vascular leakage in patients with AML, a similar assessment of vascular function by MRI must be assessed in patients that do not have AML. It is expected that 20 participants with AML will take part in this study, along with 5 healthy participants to act as a control group.