TOWARDS AN INCREASED CLINICAL IMPACT OF FOCUSED ULTRASOUND
Chrit Moonen
Imaging Division, University Medical Center, The Netherlands
E-mail C.Moonen@umcutrecht.nl
HIFU is a disruptive, minimally invasive, therapeutic technology in medicine, and its history
follows the nature cycle from the inventive stage, technical developments, preclinical and
clinical applications. Following early promise by the Fry brothers, the advent of image
guidance and many technical refinements, clinical applications started with prostate cancer,
and have since broadened considerably to other tumors, and include not only tissue ablation
but also drug delivery and immune system stimulation. The current status and progress is
well described by the FUSFoundation annual reports. Although HIFU fits well in current
strategies of personalized and precision medicine, of patient Quality-of-Life, clinical adoption
of HIFU is slow, and adequate reimbursement is often lacking. Here, the hurdles for further
progress are analyzed. A comparison is made between HIFU and recent developments in
RadioTherapy. Clinical workflow for HIFU and RadioTherapy are similar, and image guidance
has become a major issue for both therapeutic technologies. The importance of moving
beyond feasibility studies of HIFU towards randomized, multi-site, clinical trials is
highlighted. Financial issues play an important role since the business model for companies
working in HIFU is very different from that in Pharma, and Radio Therapy, and it is hard to
find financial support for such Phase 3 trials. For hospitals, HIFU equipment is an additional
investment, not replacing other modalities. Sufficient patient numbers have to be treated to
guarantee a return on investment. In addition, since HIFU is a disruptive technology, FDA
approval based on 510k clearance, is not possible and hence, regulatory issues are more
difficult for HIFU than for RadioTherapy. Nevertheless, recent highlights in the treatment of
essential tremor, its increasing share in prostate cancer therapy and in uterine fibroid
treatment, show that it is possible to increase the clinical impact of HIFU. As patient
awareness of HIFU is increasing, HIFU is finding its way into the clinic.
Chrit Moonen
Imaging Division, University Medical Center, The Netherlands
E-mail C.Moonen@umcutrecht.nl
HIFU is a disruptive, minimally invasive, therapeutic technology in medicine, and its history
follows the nature cycle from the inventive stage, technical developments, preclinical and
clinical applications. Following early promise by the Fry brothers, the advent of image
guidance and many technical refinements, clinical applications started with prostate cancer,
and have since broadened considerably to other tumors, and include not only tissue ablation
but also drug delivery and immune system stimulation. The current status and progress is
well described by the FUSFoundation annual reports. Although HIFU fits well in current
strategies of personalized and precision medicine, of patient Quality-of-Life, clinical adoption
of HIFU is slow, and adequate reimbursement is often lacking. Here, the hurdles for further
progress are analyzed. A comparison is made between HIFU and recent developments in
RadioTherapy. Clinical workflow for HIFU and RadioTherapy are similar, and image guidance
has become a major issue for both therapeutic technologies. The importance of moving
beyond feasibility studies of HIFU towards randomized, multi-site, clinical trials is
highlighted. Financial issues play an important role since the business model for companies
working in HIFU is very different from that in Pharma, and Radio Therapy, and it is hard to
find financial support for such Phase 3 trials. For hospitals, HIFU equipment is an additional
investment, not replacing other modalities. Sufficient patient numbers have to be treated to
guarantee a return on investment. In addition, since HIFU is a disruptive technology, FDA
approval based on 510k clearance, is not possible and hence, regulatory issues are more
difficult for HIFU than for RadioTherapy. Nevertheless, recent highlights in the treatment of
essential tremor, its increasing share in prostate cancer therapy and in uterine fibroid
treatment, show that it is possible to increase the clinical impact of HIFU. As patient
awareness of HIFU is increasing, HIFU is finding its way into the clinic.
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