MR Elastography (MRE) for non-invasive diagnosis, staging and monitoring of cancer and fibrosis

 

Summary

The detection of pathological tissue alterations by manual palpation is a simple but essential diagnostic tool used by clinicians.  The "virtual palpation" of tissue has now become feasible using Magnetic Resonance Elastography (MRE).  Researchers at King’s College London have developed novel MRE units that work alongside standard MRI scanners to provide high quality information on tissue characteristics following application of controlled vibrational stresses to a patient.  With many disease states impacting upon biomechanics, the potential of this non-invasive method for early diagnosis, staging and follow-up of pathologies is enormous.

 

Background

The detection of pathological tissue alterations by manual palpation is a simple but essential diagnostic tool, applied by physicians since the beginning of medicine. Recently, the virtual “palpation” of tissue has become feasible using Magnetic Resonance Elastography (MRE). With many pathologies such as cancer, cardiovascular diseases, and neuro-degenerative diseases impacting biomechanics, the potential of this novel non-invasive method for early diagnosis, staging, and therapy follow up is enormous. Results obtained in patients with cancers and fibrosis have demonstrated impressive initial results and further funded clinical studies are underway. MRE quantifies in-vivo biomechanical properties of tissue by analysing the propagation of externally elicited, low magnitude, shear waves. This method requires three steps:

 

1. sending low-frequency mechanical waves into the body via an externally applied transducer,

2. imaging waves via dedicated MRI motion sensitized data acquisition sequences, and

3. performing image analysis to generate false-colour images of the biomechanical properties.

 

Why

While widely used, biopsies cause localised tissue damage eliciting inflammatory and/or repair responses, as well as possibly missing discrete tumours within a tissue. Previous MRE approaches have lacked efficiency, precision, reproducibility and patient-friendliness, hampering its broad clinical acceptance and adoption. MRE has started to be commercialized by Mayo Clinic Rochester (resoundant.com), using a pneumatic approach: However, although FDA-approved, this device produces unreliable mechanical excitation.  Other researchers use either metal-containing electromagnetic drivers or bulky long rigid rods reaching into the bore of the MRI machine.

 

What

Led by Prof. Ralph Sinkus, King’s researchers have invented a novel MRE unit that works alongside standard commercially available MRI scanners to provide information on tissue characteristics. The approach provides controlled and non-distorted oscillating stress to a subject under assessment. The prototypes employ drivers positioned remotely to the subject outside the MR field.  In one prototype, the mechanical waves generated by the driver are transmitted via a semi-flexible rod guided to various front-ends which are in direct contact with the patient. In the most advanced prototype, the driver rotates a long, flexible spindle which produces vibrations via an eccentric weight in a container in direct contact with the patient.

Due to the modular nature of the invention the standard drive module can be used with a number of different front transmission sections. Each front section can be designed to address the specific organ that is to be imaged (e.g. brain, breast, cardiac, liver, uterus, kidney) and it is possible, via gears in the near-patient unit, to generate more than one vibrational frequency, thereby permitting the capture of more detailed information about the tissues' properties during a scanning session.

  

Opportunity

A number of collaborative clinical studies involving industry are underway involving diagnosis of breast cancer, brain tumours, Alzheimer’s Disease and abdominal tumours and fibrosis.  Although the MRE technology is being used in the studies, King’s retains all the rights over the device innovations.  King’s wishes to explore establishing a commercial mechanism with a development partner to take forward the manufacture, registration and marketing of the devices for research and clinical applications.

 

Intellectual Property

A priority application was filed in February 2015 and an International PCT application followed in February 2016 (App. No. PCT/GB2016/050490).  The Written Opinion and International Search Report consider a proportion of the claims to be novel and inventive.  National Phase has been entered in China, Japan, Europe and USA, during August 2017 and the first office actions in each jurisdiction are awaited. 

 

 

Patent Information:
For Information, Contact:
Ceri Mathews
IP & Licensing Manager
King's College London
ceri.mathews@kcl.ac.uk
Inventors:
Ralph Sinkus
Ondrej Holub
Simon Lambert
Rachel Clough
Keywords: