R.O. Illing

The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

High-intensity focused ultrasound (HIFU) provides a potential noninvasive alternative to conventional therapies. We report our preliminary experience from clinical trials designed to evaluate the safety and feasibility of a novel, extracorporeal HIFU device for the treatment of liver and kidney tumours in a Western population. The extracorporeal, ultrasound-guided Model-JC Tumor Therapy System (HAIFU™ Technology Company, China) has been used to treat 30 patients according to four trial protocols. Patients with hepatic or renal tumours underwent a single therapeutic HIFU session under general anaesthesia. Magnetic resonance imaging 12 days after treatment provided assessment of response. The patients were subdivided into those followed up with further imaging alone or those undergoing surgical resection of their tumours, which enabled both radiological and histological assessment. HIFU exposure resulted in discrete zones of ablation in 25 of 27 evaluable patients (93%). Ablation of liver tumours was achieved more consistently than for kidney tumours (100 vs 67%, assessed radiologically). The adverse event profile was favourable when compared to more invasive techniques. HIFU treatment of liver and kidney tumours in a Western population is both safe and feasible. These findings have significant implications for future noninvasive image-guided tumour ablation.

Is it time to consider a role for MRI before prostate biopsy

The use of MRI in prostate cancer management is controversial and current guidelines underplay its role. Technological advances over the past 5 years, however, demand a re-evaluation of this position. In this article, we propose an increased use of MRI, not only in those with a diagnosis of prostate cancer but also for men before a prostate biopsy. The use of MRI before a biopsy can serve as a triage test in men with raised serum prostate-specific antigen levels, in order to select those for biopsy with significant cancer that requires treatment. This strategy could avoid biopsy, and hence unnecessary treatment, in those with no disease or insignificant cancer. In addition, avoidance of postbiopsy artifact caused by hemorrhage will lead to better local staging accuracy, while determining more accurately the disease burden. This approach could improve risk stratification by selecting those who require adjuvant therapy or dose escalation. Furthermore, MRI evaluation of cancer burden could be important in active surveillance regimens to select those needing intervention.

Will focal therapy become a standard of care for men with localized prostate cancer

The current treatment choice for men with localized prostate cancer lies between active surveillance and radical therapy. The difference between these two extremes of care is 5% in terms of cancer-related absolute mortality at 8 years. It is generally accepted that this small difference will decrease for men diagnosed in the prostate-specific-antigen era. Radical therapy is associated with considerable adverse effects (e.g. incontinence, impotence, rectal problems) because it treats the whole gland, and damages surrounding structures in up to half of men. Men are being diagnosed at a younger age with lower-risk disease, and many have unifocal or unilateral disease. We propose a new concept whereby only the tumor focus and a margin of normal tissue are treated. This paradigm might decrease adverse effects whilst, at the same time, retaining effective cancer control. The arguments for and against active surveillance and radical therapy are reviewed in this article, with focal therapy presented as a means for bridging these two approaches.

High-intensity-focused ultrasound in the treatment of primary prostate cancer: the first UK series

Background:The use of minimally invasive ablative therapies in localised prostate cancer offer potential for a middle ground between active surveillance and radical therapy.Methods:An analysis of men with organ-confined prostate cancer treated with transrectal whole-gland HIFU (Sonablate 500) between 1 February 2005 and 15 May 2007 was carried out in two centres. Outcome data (side-effects using validated patient questionnaires, biochemical, histology) were evaluated.Results:A total of 172 men were treated under general anaesthetic as day-case procedures with 78% discharged a mean 5 h after treatment. Mean follow-up was 346 days (range 135–759 days). Urethral stricture was significantly lower in those with suprapubic catheter compared with urethral catheters (19.4 vs 40.4%, P=0.005). Antibiotics were given to 23.8% of patients for presumed urinary tract infection and the rate of epididymitis was 7.6%. Potency was maintained in 70% by 12 months, whereas mild stress urinary incontinence (no pads) was reported in 7.0% (12 out of 172) with a further 0.6% (1 out of 172) requiring pads. There was no rectal toxicity and no recto-urethral fistulae. In all, 78.3% achieved a PSA nadir ⩽0.5 μg ml−1 at 12 months, with 57.8% achieving ⩽0.2 μg ml−1. Then, 8 out of 13 were retreated with HIFU, one had salvage external beam radiotherapy and four chose active surveillance for small-volume low-risk disease. Overall, there was no evidence of disease (PSA <0.5 μg ml−1 or negative biopsy if nadir not achieved) after one HIFU session in 92.4% (159 out of 172) of patients.Conclusion:HIFU is a minimally invasive, day-case ablative technique that can achieve good biochemical outcomes in the short term with minimal urinary incontinence and acceptable levels of erectile dysfunction. Long-term outcome needs further evaluation and the inception of an international registry for cases treated using HIFU will significantly aid this health technology assessment.

Extracorporeal high intensity focused ultrasound for renal tumours: a 3-year follow-up.

Study Type – Therapy (case series)
Level of Evidence 4

Visually directed high-intensity focused ultrasound for organ-confined prostate cancer: a proposed standard for the conduct of therapy

To propose a standard for the conduct of visually directed transrectal high‐intensity focused ultrasound (HIFU) and to offer a formal description of the changes observed on B‐mode ultrasonography (US) during this procedure. We describe our early experience of using two different treatment methods; algorithm‐based HIFU and visually directed HIFU for the treatment of organ‐confined prostate cancer.

High-intensity focused ultrasound treatment of liver tumours: post-treatment MRI correlates well with intra-operative estimates of treatment volume

OBJECTIVES To assess the safety and feasibility of high-intensity focused ultrasound (HIFU) ablation of liver tumours and to determine whether post-operative MRI correlates with intra-operative imaging. METHODS 31 patients were recruited into two ethically approved clinical trials (median age 64; mean BMI 26 kg m(-2)). Patients with liver tumours (primary or metastatic) underwent a single HIFU treatment monitored using intra-operative B-mode ultrasound. Follow-up consisted of radiology and histology (surgical trial) or radiology alone (radiology trial). Radiological follow-up was digital subtraction contrast-enhanced MRI. RESULTS Treatment according to protocol was possible in 30 of 31 patients. One treatment was abandoned because of equipment failure. Transient pain and superficial skin burns were seen in 81% (25/31) and 39% (12/31) of patients, respectively. One moderate skin burn occurred. One patient died prior to radiological follow-up. Radiological evidence of ablation was seen in 93% (27/29) of patients. Ablation accuracy was good in 89% (24/27) of patients. In three patients the zone of ablation lay ≤2 mm outside the tumour. The median cross-sectional area (CSA) of the zone of ablation was 5.0 and 5.1 cm(2) using intra-operative and post-operative imaging, respectively. The mean MRI:B-mode CSA ratio was 1.57 [95% confidence interval (CI)=0.57-2.71]. There was positive correlation between MRI and B-mode CSA (Spearmans r=0.48; 95% CI 0.11-0.73; p=0.011) and the slope of linear regression was significantly non-zero (1.23; 95% CI=0.68-1.77; p<0.0001). CONCLUSIONS HIFU ablation of liver tumours is safe and feasible. HIFU treatment is accurate, and intra-operative assessment of treatment provides an accurate measure of the zone of ablation and correlates well with MRI follow-up.

MR Imaging of Nonmalignant Penile Lesions

Magnetic resonance (MR) imaging is potentially useful in the assessment of many benign penile diseases. When T1- and T2-weighted sequences are used, MR imaging can clearly delineate the tunica albuginea and can be used to diagnose penile fracture and Peyronie disease; in both conditions, MR imaging may help refine the surgical approach. It is also useful in cases of priapism; in these cases, intravenously administered contrast material can help assess the viability of the corpora cavernosa and the presence of penile fibrosis. In the assessment of a penile prosthesis, MR imaging provides excellent anatomic information and is the investigation of choice. In the evaluation of erectile dysfunction, MR imaging has limited value, and for urethral stricture, it has not yet proved adequately superior to other modalities to justify its routine use.

High-intensity focused ultrasound ablation of liver tumours: can radiological assessment predict the histological response?

Cancer therapies usually depend on cross-sectional imaging for the assessment of treatment response. This study was designed to evaluate the ability of MRI to predict zones of necrosis following the use of high-intensity focused ultrasound (HIFU) to treat liver metastases. Patients with liver metastases, who had been scheduled for elective surgical resection of their tumours, were recruited to this non-randomized Phase II study. In each case, a proportion of an index liver tumour target was ablated. The response to HIFU was assessed after 12 days using contrast-enhanced MRI and compared directly with histological analysis at the time of surgery. Eight patients were treated, of whom six were subsequently assessed with both MRI and histology. There were no major complications. MRI predicted complete ablation in three cases. In each case, histological analysis confirmed complete ablation. In one case, the region of ablation observed on MRI appeared smaller than predicted at the time of HIFU, but histology revealed complete ablation of the target region. The predominant characteristic of HIFU-ablated tissue was coagulative necrosis but heat fixation was evident in some areas. Heat-fixed cells appeared normal under haematoxylin and eosin staining, indicating that this is unreliable as an indicator of HIFU-induced cell death. This study demonstrates that HIFU is capable of achieving selective ablation of pre-defined regions of liver tumour targets, and that MRI evidence of complete ablation of the target region can be taken to infer histological success.

The incidence of chronic scrotal pain after vasectomy : a prospective audit

To assess the extent of scrotal pain in men before and after vasectomy, to produce accurate data for the benefit of men considering this procedure, and hence improved informed consent about the outcomes, as chronic scrotal pain after vasectomy is a poorly quantified clinical problem.