Implementation of a computed tomography dose management program across a multinational healthcare organization.

OBJECTIVES: Radiation dose index monitoring (RDIM) systems may help identify CT dose reduction opportunities, but variability and complexity of imaging procedures make consistent dose optimization and standardization a challenge. This study aimed to investigate the feasibility to standardize and optimize CT protocols through the implementation of a Dose Excellence Program within a European healthcare network. METHODS: The Dose Excellence Program consisted of a multidisciplinary team that developed standardized organizational adult CT protocols and thresholds for relevant radiation dose indices (RDIs). Baseline data were collected retrospectively from the RDIM (Phase I, 2015). Organization's protocols were implemented and monitored from the RDIM for deviations (Phase II, 2016). Following standardization, radiation dose optimization was initiated (Phase III, 2017). Data from the three most used protocols were retrospectively extracted and grouped by country for all phases. The mean number of series (RS) and RDIs were compared between phases and with organizational reference levels. A Mann-Whitney test was conducted; p < .05 was considered as significant. RESULTS: Data from 9588, 12638, and 6093 examinations were analyzed from General Chest, General Head, and Thorax/Abdomen/Pelvis (TAP) multiphase respectively. Overall, after Phase III, mean RS and CTDIvol p75 were below the organizational reference levels in all countries for the three protocols. The CTDIvol decreased by 45% in Switzerland (p < .00001), 32% in Turkey (p < .00001), and 28% in Switzerland (p = .0027) for General Chest, General Head, and TAP multiphase respectively. CONCLUSIONS: The implementation of a Dose Excellence Program within a large-scale healthcare organization allowed unifying protocols and optimizing radiation dose across countries. KEY POINTS: • Engaging a multidisciplinary team can enhance the use of an RDIM system for CT dose management in a multinational healthcare environment. • Deep dive of baseline data and standardization of CT practices by defining organizational clinical indication CT protocols with RPIDs is an essential step before optimization of radiation dose. • Following the implementation of the program, the mean RS and CTDIvol were below or equal to the organizational reference levels in all countries.

Perivascular extension of microwave ablation zone: demonstrated using an ex vivo porcine perfusion liver model.

Microwave ablation (MWA) has been proposed to suffer less from the heat sink effect compared to radiofrequency ablation but has been reported to cause extension of the ablation zone along intrahepatic vessels in clinical practice. To study this effect in detail, eight fresh porcine livers were perfused in an ex vivo organ perfusion system. Livers were perfused with oxygenated, O-positive human blood at 37 °C. Perfusion was discontinued immediately before ablation in the non-perfused group (n = 4) whilst in the perfused group (n = 4) perfusion was maintained during MWA (140 W X 2 min). Large intrahepatic vessels (> 6 mm) were avoided using ultrasound. MWA zones were bisected within 30 min of perfusion termination and sections were fixed in formalin and stained with H&E and NADH to assess cell viability. Magnetic resonance imaging (MRI) was performed on two livers (one perfused, one non-perfused) to provide imaging correlation before sectioning. Twenty-one out of a total of 30 MW ablation zones (70%) showed extension of the ablation zone along a vessel. There was no statistically significant difference (p = 1) in the incidence of ablation zone extension between perfused (9/13, 69%) and non-perfused organs (12/17, 71%). MRI also demonstrated ablation zone extension along blood vessels correlating with macroscopy in two livers. NADH staining also confirmed extension of the ablation zone. Liver MWA appears to be commonly associated with propagated thermal injury along adjacent vessels and occurs independent of active blood flow. In order to avoid possible complications through non-target tissue injury, this effect requires further investigation.

Effect of Hepatic Perfusion on Microwave Ablation Zones in an Ex Vivo Porcine Liver Model.

PURPOSE: To compare the size of ablation zones derived from nonperfused ex vivo livers with ablation zones created using an ex vivo perfused porcine liver model. MATERIALS AND METHODS: Six fresh porcine livers were used to evaluate microwave ablation (MWA). Perfused (n = 3) and nonperfused (n = 3) livers were warmed to 37°C by oxygenated, O-positive human blood reconstituted with Ringer solution, using an organ perfusion circuit. During MWA, perfusion was discontinued in the nonperfused group and maintained in the perfused group. After MWA (140 watts × 2 min at 2.45 GHz) with the Acculis MTA System (AngioDynamics, Latham, New York), ablation zones were bisected sagittally. Sections were stained with nicotinamide adenine dinucleotide (NADH) and hematoxylin-eosin to assess viability of cells in ablation and marginal zones. RESULTS: Comparison of 22 MWA zones (9 in perfused group, 13 in nonperfused group) was performed. Ablation zones demonstrated a central "white" and peripheral "red" zone. Cells in the white zone were nonviable with no NADH staining. The red zone showed progressive NADH staining toward the periphery, suggesting incomplete cell death. White and red zones of the perfused group were significantly smaller compared with the nonperfused group (short axis, 17.8 mm ± 2.7 vs 21.1 mm ± 3.2, P = .003; long axis, 40.69 mm ± 3.9 vs 39.63 mm ± 5.2, P = .44; intermediate zone,1.33 mm ± 0.04 vs 2.7 mm ± 0.14, P < .0001; mean ± SD). CONCLUSIONS: MWA algorithms provided by this manufacturer are based on nonperfused organ data, which overestimate ablation zone size. Data from perfused liver models may be required for more accurate dosimetry guidelines.

Percutaneous High-Energy Microwave Ablation for the Treatment of Pulmonary Tumors: A Retrospective Single-Center Experience.

PURPOSE: To evaluate the safety and efficacy of percutaneous high-energy microwave ablation (MWA) for the treatment for pulmonary tumors. MATERIALS AND METHODS: A retrospective review was undertaken of 44 patients (21 men, 23 women; median age, 66 y; range, 17-89 y) who underwent 62 sessions of high-energy MWA for 87 pulmonary tumors at a single tertiary referral center between June 2012 and June 2014. Primary tumor origin was sarcoma (n = 23), colorectal (n = 16), lung (n = 2), esophageal (n = 1), breast (n = 1), and bladder (n = 1). Median tumor size was 12 mm (range, 6-45 mm). Technical success was recorded contemporaneously, complication rate at 30 days was recorded prospectively, and technique effectiveness was assessed by longitudinal follow-up CT scan. RESULTS: Primary technical success was achieved in 94% of ablation sessions. The median follow-up interval was 15 months (range, 6.2-29.5 mo) during which time local tumor progression was observed in two of 87 tumors (technique effectiveness 98%). Pneumothorax requiring chest tube insertion occurred in 19%; delayed pneumothorax occurred in four patients. No hemoptysis, infection, or other complications were recorded. CONCLUSIONS: High-energy MWA is safe and effective for the destruction of lung tumors.

Bacteria in sputum of stable severe asthma and increased airway wall thickness.

BACKGROUND: Patients with chronic asthma have thicker intrapulmonary airways measured on high resolution computed tomography (HRCT). We determined whether the presence of lower airway bacteria was associated with increased airway wall thickness. METHODS: In 56 patients with stable severe asthma, sputum specimens obtained either spontaneously or after induction with hypertonic saline were cultured for bacteria and thoracic HRCT scans obtained. Wall thickness (WT) and area (WA) expressed as a ratio of airway diameter (D) and total area, respectively, were measured at five levels. RESULTS: Positive bacterial cultures were obtained in 29 patients, with H. influenzae, P. aeruginosa and S. aureus being the commonest strains. Logistic regression analysis showed that this was associated with the duration of asthma and the exacerbations during the past year. In airways > 2 mm, there was no significant difference in WA (67.5 ± 5.4 vs 66.4 ± 5.4) and WT/D (21.6 ± 2.7 vs 21.3 ± 2.4) between the culture negative versus positive groups. Similarly, in airways (≤ 2 mm), there were no significant differences in these parameters. The ratio of √wall area to Pi was negatively correlated with FEV1% predicted (p < 0.05). CONCLUSIONS: Bacterial colonization of the lower airways is common in patients with chronic severe asthma and is linked to the duration of asthma and having had exacerbations in the past year, but not with an increase in airway wall thickness.

Artificial intelligence and machine learning in cancer imaging.

An increasing array of tools is being developed using artificial intelligence (AI) and machine learning (ML) for cancer imaging. The development of an optimal tool requires multidisciplinary engagement to ensure that the appropriate use case is met, as well as to undertake robust development and testing prior to its adoption into healthcare systems. This multidisciplinary review highlights key developments in the field. We discuss the challenges and opportunities of AI and ML in cancer imaging; considerations for the development of algorithms into tools that can be widely used and disseminated; and the development of the ecosystem needed to promote growth of AI and ML in cancer imaging.

Artificial intelligence for reduced dose 18F-FDG PET examinations: a real-world deployment through a standardized framework and business case assessment.

BACKGROUND: To determine whether artificial intelligence (AI) processed PET/CT images of reduced by one-third of 18-F-FDG activity compared to the standard injected dose, were non-inferior to native scans and if so to assess the potential impact of commercialization. MATERIALS AND METHODS: SubtlePET™ AI was introduced in a PET/CT center in Italy. Eligible patients referred for 18F-FDG PET/CT were prospectively enrolled. Administered 18F-FDG was reduced to two-thirds of standard dose. Patients underwent one low-dose CT and two sequential PET scans; "PET-processed" with reduced dose and standard acquisition time, and "PET-native" with an elapsed time to simulate standard acquisition time and dose. PET-processed images were reconstructed using SubtlePET™. PET-native images were defined as the standard of reference. The datasets were anonymized and independently evaluated in random order by four blinded readers. The evaluation included subjective image quality (IQ) assessment, lesion detectability, and assessment of business benefits. RESULTS: From February to April 2020, 61 patients were prospectively enrolled. Subjective IQ was not significantly different between datasets (4.62±0.23, p=0.237) for all scanner models, with "almost perfect" inter-reader agreement. There was no significant difference between datasets in lesions' detectability, target lesion mean SUVmax value, and liver mean SUVmean value (182.75/181.75 [SD:0.71], 9.8/11.4 [SD:1.13], 2.1/1.9 [SD:0.14] respectively). No false-positive lesions were reported in PET-processed examinations. Agreed SubtlePET™ price per examination was 15-20% of FDG savings. CONCLUSION: This is the first real-world study to demonstrate the non-inferiority of AI processed 18F-FDG PET/CT examinations obtained with 66% standard dose and a methodology to define the AI solution price.

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

OBJECTIVE: To determine whether primary extracorporeal high-intensity focused ultrasound (HIFU) is safe, feasible and effective for managing small renal tumours. PATIENTS AND METHODS: Although surgery currently remains the standard treatment for localized renal cell carcinoma (RCC), the increasing incidence of small renal cancers has led to a shift towards nephron-sparing surgery, with associated morbidity in 20-25% of cases, and minimally invasive ablative therapies present an alternative management. HIFU results in 'trackless' homogenous tissue ablation and when administered via an extracorporeal device, is entirely noninvasive. The study comprised 17 patients (mean tumour size 2.5 cm) with radiologically suspicious renal tumours who underwent extracorporeal HIFU using the Model-JC System (Chongqing HAIFU™, China), under general anaesthesia with one overnight hospital stay. Real-time diagnostic ultrasonography was used for targeting and monitoring. Patients were followed with a clinical review and gadolinium-enhanced magnetic resonance imaging at 12 days and every 6 months for a mean of 36 months. The outcomes measures were patient morbidity and oncological efficacy of HIFU treatment. RESULTS: Of the 17 patients, 15 were treated according to protocol; two procedures were abandoned due to intervening bowel. There were no major complications related to HIFU. Radiological evidence of ablation was apparent at 12 days in seven of the 15 patients. Before the 6-month follow-up one patient had surgery due to persisting central enhancement. Fourteen patients were evaluated at the 6-month follow-up; eight tumours had involuted (mean 12% decrease in tumour area). Four patients had irregular enhancement on imaging and had alternative therapies. Ten patients remain on follow-up at a mean (range) of 36 (14-55) months after HIFU (mean 30% decrease in tumour area). There was central loss of enhancement in all. CONCLUSIONS: Renal HIFU achieves stable lesions in two-thirds of patients, with minimal morbidity, and might be appropriate in selected cases. Further trials with accurate histological follow-up are essential to fully evaluate this novel technique.

Role of Smoking in the Evolution of Cardiovascular Magnetic Resonance and Laboratory Findings of Acute Myocarditis.

PURPOSE: The purpose is to investigate cardiac magnetic resonance and laboratory findings in patients with clinically suspected acute myocarditis and re-assess the evolution of findings in relation to clinical parameters and smoking habits. METHODS: We prospectively analyzed 68 consecutive patients (4 females, 64 males, median age 25 years) at baseline and 51 patients 12 months later with regard to age, symptoms, and signs, smoking history, cardiac troponin I, erythrocyte sedimentation rate, c-reactive protein blood levels, electrocardiography changes, and cardiac magnetic resonance findings. Statistical analysis included group comparisons and linear regression between clinical parameters and the obtained data. RESULTS: A statistically significant correlation was recorded between smoking and late gadolinium enhancement extent, both at baseline and follow-up study. Late gadolinium enhancement extent was positively associated with cardiac troponin I serum levels and c-reactive protein and negatively with left ventricular ejection fraction at baseline study. Myocardial segments 4 and 5 were most frequently involved. Late gadolinium enhancement persisted in 96% of patients with no significant extent change at 12-month follow-up, while improved. CONCLUSIONS: A strong correlation was recorded between smoking patients with acute myocarditis and extent both at baseline and follow-up cardiac magnetic resonance. Myocardial segments 4 and 5 involvement was most prevalent. Late gadolinium enhancement persisted at follow-up, its incidence was higher than that reported in other studies and did not have an impact on the patient's clinical status or cardiac function. However, longer-term follow-up is highly recommended in these patients.

Lead exposure in clinical imaging - The elephant in the room.

PURPOSE: Radiation Protection Apparel (RPA) is used during diagnostic imaging and interventional procedures to minimise incidental radiation exposure. The majority of RPA in use are lead-containing, which has until now been considered safe. A recent single-centre study has demonstrated that the external surface of 63 % of RPA was contaminated with lead dust. The purpose of this study was to reproduce this investigation with a larger sample size across Europe and assess whether decontamination procedures were possible. METHOD: The routine RPA Quality Control (QC) process was adapted to include lead dust contamination tests and decontamination if present. The presence of lead dust was determined using a commercially available colorimetric method. RPA that failed initial QC or could not be decontaminated were removed from use. RESULTS: From June to October 2019, 728 RPA from 85 imaging centres from five countries underwent initial QC. Of these, 712 were tested for lead dust contamination which was present on 162 (23 %). Following cleaning, 85 (12 %) remained contaminated and were removed from use. Linear regression analysis shows a significant correlation between type of RPA and contamination, (p = 0.0015). There was no correlation between contamination and imaging department, year of manufacture, country and RPA condition (p-values 0.98, 0.90, 0.94 and 0.14 respectively). CONCLUSIONS: Lead dust contamination is present on 23 % of RPA that would pass routine QC procedures. Approximately half were not amenable to decontamination and were removed from use. Procedures were introduced for the routine handling of RPA, and updated QC steps for assessment and cleaning. Lead-free RPA should be considered.

Rectal fistulae after salvage high-intensity focused ultrasound for recurrent prostate cancer after combined brachytherapy and external beam radiotherapy.

OBJECTIVE: To report on the high rectal fistula rate associated with salvage high-intensity focused ultrasound (HIFU) after the failure of combined brachytherapy and external beam radiotherapy (EBRT) for prostate cancer; salvage ablative therapy for prostate cancer is indicated when there is local recurrence after RT, brachytherapy or their combination. PATIENTS AND METHODS: We retrospectively reviewed all men with prostate cancer treated with HIFU between 1 March 2005 and 31 May 2007, and identified five men treated after the failure of both brachytherapy and EBRT for localized prostate cancer. RESULTS: Three of the five men had iodine-seed implantation brachytherapy combined with EBRT as primary treatment, one had high-dose rate brachytherapy combined with EBRT and one had salvage iodine-seed brachytherapy for failed EBRT. Three of the five patients developed a recto-urethral fistula after HIFU. CONCLUSIONS: The high rate of recto-urethral fistula formation in this group might reflect an impaired blood supply or HIFU-associated near-field heating of the rectal wall. Tissue viability and healing might affect this group regardless of the salvage method. Careful patient selection and avoidance of rectal diagnostic biopsies might minimize the risk. Emerging ablative therapies regarded as less invasive than traditional therapies must be used with caution.

MR imaging of prostate after treatment with high-intensity focused ultrasound.

PURPOSE: To prospectively evaluate magnetic resonance (MR) imaging findings after high-intensity focused ultrasound (HIFU) treatment of the prostate and to correlate them with clinical and histologic findings. MATERIALS AND METHODS: Local ethics committee approval and informed consent were obtained. Fifteen consecutive men aged 46-70 years with organ-confined prostate cancer underwent ultrasonographically guided ablation of the whole prostate. Postoperative MR images were obtained within 1 month (12 patients), at 1-3 months (five patients), and in all patients at 6 months. Prostate volume was measured on T2-weighted images, and enhancing tissue was measured on dynamic images after intravenous administration of gadopentetate dimeglumine. Prostate-specific antigen (PSA) level was measured at regular intervals, and transrectal biopsy was performed in each patient at 6 months after treatment. RESULTS: Initial post-HIFU images showed a central nonenhancing area, surrounded by an enhancing rim. At 6 months, the prostate was small (median volume reduction, 61%) and was of predominantly low signal intensity on T2-weighted images. The volume of prostate enhancing on the initial posttreatment image correlated well with serum PSA level nadir (Spearman r = 0.90, P < .001) and with volume at 6 months (Pearson r = 0.80, P = .001). The three patients with the highest volume of enhancing prostate at the initial posttreatment acquisition had persistent cancer at 6-month biopsy. CONCLUSION: MR imaging results of the prostate show a consistent sequence of changes after treatment with HIFU and can provide information to the operator about completeness of treatment.

The feasibility and safety of high-intensity focused ultrasound as salvage therapy for recurrent prostate cancer following external beam radiotherapy.

OBJECTIVES: To investigate the use of minimally invasive high-intensity focused ultrasound (HIFU) as a salvage therapy in men with localized prostate cancer recurrence following external beam radiotherapy (EBRT). PATIENTS AND METHODS: A review of 31 cases treated using the Sonablate 500 HIFU device, between 1 February 2005 and 15 May 2007, was carried out. All men had presumed organ-confined, histologically confirmed recurrent prostate adenocarcinoma following EBRT. RESULTS: The mean (range) age was 65 (57-80) years with a mean preoperative PSA level of 7.73 (0.20-20) ng/mL. The patients were followed for a mean (range) of 7.4 (3-24) months. Side-effects included stricture or intervention for necrotic tissue in 11 of the 31 patients (36%), urinary tract infection or dysuria syndrome in eight (26%), and urinary incontinence in two (7%). Recto-urethral fistula occurred in two men, although one was due to patient movement due to inadequate anaesthesia, so the 'true' rate is 3%. Half of the patients had PSA levels of <0.2 ng/mL at the last follow-up. Three patients had metastatic disease whilst another two had only local, histologically confirmed, failure. A further four patients had evidence of biochemical failure only. Overall, 71% had no evidence of disease following salvage HIFU. CONCLUSIONS: Salvage HIFU is a minimally invasive daycase procedure that can achieve low PSA nadirs and good cancer control in the short term, with comparable morbidity to other forms of salvage treatment. The issue of accurate staging at the time of recurrence is still problematic, as a proportion of these men will harbour microscopic metastases undetected by conventional staging investigations.

Endorectal magnetic resonance imaging and magnetic resonance spectroscopy to monitor the prostate for residual disease or local cancer recurrence after transrectal high-intensity focused ultrasound.

OBJECTIVE: To assess the role of magnetic resonance imaging (MRI) for evaluating changes in the prostate after transrectal high-intensity focused ultrasound (HIFU) for treating prostate cancer, correlating the findings with histology to assess its possible role in predicting the outcome, evaluating residual cancer or local recurrence of disease. PATIENTS AND METHODS: Ten patients with prostate cancer were assessed with MR and MR spectroscopy (MRS) before and at 1, 4 and 12 months after HIFU, assessing the glandular volume and MRI and MRS data after HIFU. These data were correlated with the prostate-specific antigen (PSA) levels at each examination (suspicious for residual cancer if >0.5 ng/mL) and with histological findings of prostate biopsy sampling at 6-8 months (random or targeted at suspicious MR areas). RESULTS: Variations in volume during the follow-up were not associated with treatment outcome. MRI was suspicious for residual cancer in one patient at 1 month and in another two at 4 months; in all three patients (one with a PSA level of <0.5 ng/mL) targeted biopsies were positive for cancer. MRI was negative in seven patients; in six of these (one with a PSA level of >0.5 ng/mL) random biopsies were negative, and in one the random biopsies were positive for residual cancer. At 4 months there was a statistically significant difference (P = 0.015) between patients responsive to treatment and those with persistent disease, by combining negative MRI with a PSA level of <0.5 ng/mL; MRS data were suitable for analysis only in three patients with partial necrosis. CONCLUSION: Our preliminary data support the role of MRI in association with PSA levels as a useful and accurate tool in the follow-up of patients treated with HIFU for prostate cancer. However, considering the economic issue, it should not be used routinely and should be limited to detecting residual cancer (in patients with a PSA level of >0.5 ng/mL) with the main purpose of improving the detection rate of transrectal ultrasonography (TRUS)-guided prostate biopsy. MRS data had no additional value over MRI. Further evaluation is needed to compare the use of contrast media and other techniques (e.g. colour Doppler TRUS) in detecting residual or local recurrent cancer.

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.

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.

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

OBJECTIVE: 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. PATIENTS AND METHODS: Between November 2004 and January 2006 nine surgeons carried out vasectomies in 625 men (mean age 39.9 years, sd 5.6) under local anaesthesia. A questionnaire was devised to establish the presence of any scrotal or testicular pain, and to characterize this discomfort; 6 months after the procedure a modified version of the same questionnaire was administered. RESULTS: In all, 593 (94.7%) men returned the preoperative questionnaires and were entered into the study; 488 (82.2%) of these completed the follow-up questionnaire, giving a mean (sd) follow-up of 6.8 (1.6) months. In all, 65 men reported new-onset scrotal pain at 7 months (14.7%). The mean visual analogue score for this pain was 3.4/10. Four men (0.9%) in the responding group described pain after vasectomy as 'quite severe and noticeably affecting their quality of life'. CONCLUSION: At 7 months after vasectomy about 15% of previously asymptomatic men have some degree of scrotal discomfort. These early data indicate that chronic scrotal pain after vasectomy is a genuine entity, but a longer-term follow-up in this group will be important to allow further evaluation of how this pain develops with time.