CLEVAR
Research type
Research Study
Full title
A clinical enabling study of bone-marrow vascular leak as measured by DCE MRI in healthy subjects and participants with AML.
IRAS ID
253568
Contact name
Jamie Cavenagh
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Studies have shown that one of the effects of acute myeloid leukaemia (AML) is damage to the blood vessels associated with bone marrow. This damage affects oxygen, nutrient and drug delivery, with increased vascular leak (fluid and protein leakage out of blood vessels) and hypoxia (lack of required oxygen in tissues/cells) and results in an increase in levels of nitric oxide (NO). This vascular leakage and increased NO levels remain following treatment and may contribute to treatment failure. A combination of NO inhibitors and chemotherapy has been suggested to provide a more effective form of treatment.
Recent results suggest that the detection of these vascular leaks could be very useful as a means of evaluating appropriate treatment. Magnetic resonance imaging (MRI) is a non-invasive imaging way to view and measure vascular function in participants. It is used to view the anatomy and the physiology of the body using applied magnetic fields and the properties of certain elements contained in the body.
This study is designed to evaluate the feasibility of using MRI scans to assess vascular leak in the bone marrow of participants with AML before and after induction (i.e. the first round of treatment) chemotherapy.
In order to provide accurate evaluation of the efficacy of MRI assessment of vascular leakage in participants with AML, a similar assessment of vascular function must be assessed in participants that do not have AML. The study will be a single-site study and aims to recruit 5 healthy volunteers and 20 participants that have been newly diagnosed with AML.
Lay summary of study results: CLEVAR was a single centre, feasibility study that aimed to evaluate the feasibility of using MRI to measure vascular leak in the bone marrow of healthy participants and participants with Acute Myeloid Leukaemia (AML). Dynamic contrast-enhanced (DCE) MRI has been chosen to measure vascular leak because it is non-invasive, does not carry a radiation risk and provides a variety of relevant endpoints that can be assessed.
The primary objective of the study was to evaluate the feasibility of using MRI to measure vascular leak in the bone marrow of healthy participants and participants with AML.
The secondary objectives were to evaluate whether vascular leak is associated with leukemic burden in participants with AML, and to assess biomarkers of vascular leak and nitric oxide in blood of healthy participants and of participants with AML before and after chemotherapy and if possible for AML participants also in BMA after chemotherapy.
The study has proven unfeasible, due to slow recruitment rates and target not being met. No results have been obtained from this study.REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1710
Date of REC Opinion
19 Feb 2020
REC opinion
Further Information Favourable Opinion