Advanced Surgery with Insterstitial capacitive Micromachined Ultrasonic Transducer for conformationnal thermal ablation of brain tumors – ASIMUT

More and more surgical techniques are evolving toward the use of minimally invasive technologies to reduce the morbidity of operations, reduce levels of pain, shorten hospital stays, and reduce associated costs. Currently, percutaneous radiofrequency (RF) or laser probes, guided in real-time by ultrasound or MRI imaging, are frequently used clinically for the successful treatment of bone, lung, liver and kidney metastases. The ASIMUT project's main objective is to replace RF or laser by high intensity focused ultrasound (HIFU), which can be focused in 3D to produce thermal injury that more closely conforms to the target tumor geometry.

ASIMUT offers an innovative approach to exploring this new therapeutic technique by using interstitial transducers incorporating capacitive micromachined ultrasound transducers (cMUTs). The clinical objective of this project is to use cMUTs in HIFU arrays to develop a device for interstitial thermotherapy that allows conformational treatment of brain tumors under local anesthesia with real-time MRI imaging guidance.

The consortium set up for the ASIMUT project includes 3 partners: Unit 556 of INSERM, a specialist in HIFU research for 20 years; Vermon, a company that has significant expertise in cMUT and ultrasound transducer technology for over a decade; and CarThera, a startup company whose primary mission is to develop innovative medical technology and to translate it to clinical practice.

ASIMUT will include significant advances in both medical and technological contexts:
• the realization of treatments that are more effective, less invasive, cost less, and that are more applicable to a significant number of patients by allowing for a single outpatient procedure that includes both diagnosis and ablation of specific brain tumors by using a MRI-guided interstitial probe.
• an innovative approach is utilized that involves interstitial ultrasound transducers incorporating cMUTs to control the local ablation of brain tumors or cancerous tissue and utilizes a miniature probe to enable this technology to produce thermal injury to the conformational target tumor without the need for cooling of the probe during treatments (these 3 features are innovations of CMUT probes compared to other research projects involving HIFU probes)

For the 3 years of the project, ASIMUT should lead to the achievement of preclinical testing in animals through the implementation of the 6 following tasks :
• Task 1: Requirements definition and clinical conditions
• Task 2: Design of the cMUT device for interstitial HIFU
• Task 3: Fabrication and characterization of the cMUT devices
• Task 4: Manufacturing of prototypes and experimental preclinical testing
• Task 5: Experimental Validation & Qualification
• Task 6: Preclinical Evaluation

In the longer term, ASIMUT is part of a more ambitious project that aims to validate clinically the use of cMUT technology for other HIFU applications. This research will also take place under the proposed consortium with INSERM parties controlling the development of HIFU devices, Vermon ensuring the design and manufacture of transducers, and CarThera providing clinical expertise and implementation of preclinical trials.