Project Description

The main emphasis of the TRANS-FUSIMO project lies on the implementation and validation of a real-time control system that is able to control the following hardware devices:

  • MR hardware for acquisition of anatomical and thermometry data,
  • FUS hardware for generating and focussing high intensity US,
  • Ultrasound tracking for tracking the movement of liver and ribs,
  • Robot arm for placement of the ultrasound transducer on supine patients.

Starting with interfacing the MR hardware the TRANS-FUSIMO control system will be able to get real-time images from the MR device. It will also be investigated to use the MR for real-time monitoring of the motion of the breathing patient in order to get information as accurate as possible and to get real-time information about the arising temperature in the body. Another possibility to track the target area is to use a diagnostic ultrasound device with real-time capability. With this information and a statistical motion model developed in the EU project FUSIMO, the steering of the FUS hardware can be performed. Thus, the TRANS-FUSIMO control system will have also the ability to communicate real-time motion information to the steering server provided by the FUS hardware company InSightec. The last hardware component is the robot arm which will place the transducer at the beginning of the procedure. 

After finishing the hardware developments, TRANS-FUSIMO performs preclinical tests as well as an animal study. In a later stage of the project a first patient study will be conducted with patients under breath-hold, i.e. without breathing motion. In the last phase of the the project a clinical trial with patients treated with MRgFUS under breathing motion will be conducted.

To enable clinical personnel to train and learn MRgFUS therapy and the TRANS-FUSIMO system, a training and learning system is implemented on the basis of patient-specific models and data recorded during interventions. This training will be available outside of the MRgFUS therapy room but can also serve as a reference and simulation support database just prior to or during preparation of a therapeutic procedure.

Objectives of the project

In recent years MR-guided focused ultrasound surgery (MRgFUS) has become a frequently applied means for the treatment of fibromyoma of uterus and of bone metastases. MRgFUS combines high intensity focused ultrasound for thermal ablation of diseased tissue with MR imaging to visualise the tumour and surrounding anatomy and to provide MR thermal feedback.

Treating tumours in moving organs with MRgFUS however presents tremendous technological challenges including motion due to breathing and shielding of the target by the rib cage. The VPH project FUSIMO aims at development of a planning system for MRgFUS capable to deal with the challenges in the treatment of moving abdominal organs.

TRANS-FUSIMO will translate the FUSIMO demonstrator into a clinically applicable system spanning the full clinical workflow of planning, conducting and assessing as well as learning from the procedure. With such an integrated system, MRgFUS can become a commercially and clinically competivie alternative to current surgical and minimal-invasive oncological interventions, thus providing a non-invasive treatment, reducing side effects and healthcare costs. The particular objectives for the TRANS-FUSIMO project are:

  • Extension of the FUSIMO demonstrator to support conducting and assessing of the intervention under breathing motion,
  • Interfacing state-of-the-art FUS hardware and imaging devices to build an integrated real-time-capable system for liver FUS,
  • Improving model components for optimized clinical workflow, real-time applicability and validated outcome prediction,
  • Allowing training and learning using the FUSIMO software system by building a case and results database,
  • Conducting of pre-clinical (phantoms, cadaver, animal) experiments with the FUSIMO system.

In a clinical trial, the feasibility of using the integrated system for neoadjuvant MRgFUS to achieve prolonged survival will be investigated.

Results & Impacts

The expected outcome of the TRANS-FUSIMO project is a real-time capable control system for MRgFUS procedures in moving abdominal organs, especially in the liver. The system will be validated during a preclinical animal trial and a clinical trial. In combination with an extended version of the FUSIMO demonstrator and a training and learning tool, TRANS-FUSIMO covers the whole pipeline for MRgFUS liver interventions: new clinical personnel is able to train such procedures by means of previous cases, actual cases can be planned and a real-time control system enables the physicians to treat the patients during free breathing.

The long-term impact of TRANS-FUSIMO lies in improving the treatment of cancer and metastases in a variety of organs and for a wide range of patients. This will contribute to substantially reducing the estimated 1.7 million deaths in Europe each year. The reduced side effects (compared to conventional surgery, systemic chemotherapy and radiation therapy) of the MRgFUS will reduce complications and consequently lead to a higher quality treatment of the patients at lower financial demand for health insurance and social welfare.