To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases.
This multicenter, prospective, single-arm, phase 2 study included 128 ...patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan–Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated.
Median size of metastases was 1.0 plus or minus 0.6 cm (0.2–4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan–Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6–99.2) and 86.6% (95% confidence interval: 78.7–91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event.
Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.
Although it is still early in its application, laser interstitial thermal therapy (LiTT) has increasingly been employed as a surgical option for patients with mesial temporal lobe epilepsy. This ...study aimed to describe mesial temporal lobe ablation volumes and seizure outcomes following LiTT across the Mayo Clinic's 3 epilepsy surgery centers.
This was a multi-site, single-institution, retrospective review of seizure outcomes and ablation volumes following LiTT for medically intractable mesial temporal lobe epilepsy between October 2011 and October 2015. Pre-ablation and post-ablation follow-up volumes of the hippocampus were measured using FreeSurfer, and the volume of ablated tissue was also measured on intraoperative MRI using a supervised spline-based edge detection algorithm. To determine seizure outcomes, results were compared between those patients who were seizure free and those who continued to experience seizures.
There were 23 patients who underwent mesial temporal LiTT within the study period. Fifteen patients (65%) had left-sided procedures. The median follow-up was 34 months (range 12-70 months). The mean ablation volume was 6888 mm3. Median hippocampal ablation was 65%, with a median amygdala ablation of 43%. At last follow-up, 11 (48%) of these patients were seizure free. There was no correlation between ablation volume and seizure freedom (p = 0.69). There was also no correlation between percent ablation of the amygdala (p = 0.28) or hippocampus (p = 0.82) and seizure outcomes. Twelve patients underwent formal testing with computational visual fields. Visual field changes were seen in 67% of patients who underwent testing. Comparing the 5 patients with clinically noticeable visual field deficits to the rest of the cohort showed no significant difference in ablation volume between those patients with visual field deficits and those without (p = 0.94). There were 11 patients with follow-up neuropsychological testing. Within this group, verbal learning retention was 76% in the patients with left-sided procedures and 89% in those with right-sided procedures.
In this study, there was no significant correlation between the ablation volume after LiTT and seizure outcomes. Visual field deficits were common in formally tested patients, much as in patients treated with open temporal lobectomy. Further studies are required to determine the role of amygdalohippocampal ablation.
Men with grade group 2 or 3 prostate cancer are often considered ineligible for active surveillance; some patients with grade group 2 prostate cancer who are managed with active surveillance will ...have early disease progression requiring radical therapy. This study aimed to investigate whether MRI-guided focused ultrasound focal therapy can safely reduce treatment burden for patients with localised grade group 2 or 3 intermediate-risk prostate cancer.
In this single-arm, multicentre, phase 2b study conducted at eight health-care centres in the USA, we recruited men aged 50 years and older with unilateral, MRI-visible, primary, intermediate-risk, previously untreated prostate adenocarcinoma (prostate-specific antigen ≤20 ng/mL, grade group 2 or 3; tumour classification ≤T2) confirmed on combined biopsy (combining MRI-targeted and systematic biopsies). MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60–70°C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring. Co-primary outcomes were oncological outcomes (absence of grade group 2 and higher cancer in the treated area at 6-month and 24-month combined biopsy; when 24-month biopsy data were not available and grade group 2 or higher cancer had occurred in the treated area at 6 months, the 6-month biopsy results were included in the final analysis) and safety (adverse events up to 24 months) in all patients enrolled in the study. This study is registered with ClinicalTrials.gov, NCT01657942, and is no longer recruiting.
Between May 4, 2017, and Dec 21, 2018, we assessed 194 patients for eligibility and treated 101 patients with MRI-guided focused ultrasound. Median age was 63 years (IQR 58–67) and median concentration of prostate-specific antigen was 5·7 ng/mL (IQR 4·2–7·5). Most cancers were grade group 2 (79 78% of 101). At 24 months, 78 (88% 95% CI 79–94) of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event (urinary tract infection) was reported. There were no treatment-related deaths.
24-month biopsy outcomes show that MRI-guided focused ultrasound focal therapy is safe and effectively treats grade group 2 or 3 prostate cancer. These results support focal therapy for select patients and its use in comparative trials to determine if a tissue-preserving approach is effective in delaying or eliminating the need for radical whole-gland treatment in the long term.
Insightec and the National Cancer Institute.
To evaluate the safety and effectiveness of percutaneous magnetic resonance (MR) imaging-guided laser ablation for the treatment of symptomatic soft tissue vascular malformations (VMs) in the face ...and neck.
An institutional review board-approved retrospective review was undertaken of all consecutive patients who underwent MR imaging-guided and monitored laser ablation for treatment of symptomatic, cervicofacial soft tissue VM. Preablation and postablation MR imaging findings were independently reviewed. Preablation and postablation VM sizes were documented. Preablation T2 signal characteristics and enhancement patterns as well as postablation change in both signal and enhancement were semiquantitatively assessed. Changes in VM size were compared using a paired t test.
Thirteen patients (women, 9; age, 14.5-69.5 years) with 13 VMs were treated for moderate-to-severe pain (n = 4), swelling/mass effect (n = 8), or predominantly cosmesis (n = 1) with 22 total ablation sessions. The baseline maximum VM diameter was 5.7 cm ± 4.2. At baseline, all VMs (100%) demonstrated variable T2-weighted signal hyperintensity and enhancement. For painful VM, the baseline pain score was 8 ± 1. Clinical follow-up was available for 10 patients. Of patients with available follow-up, 3 (100%) treated for moderate-to-severe pain and 7 (100%) treated for swelling/mass effect reported subjective complete or partial symptomatic relief. The patient treated predominantly for cosmetic reasons was lost to follow-up. Two patients (15.4%) experienced minor adverse events by the Society of Interventional Radiology standards. There were no major adverse events.
MR imaging-guided and monitored percutaneous laser ablation is safe and effective for the treatment of symptomatic, cervicofacial VMs.
Mixed manganese–zinc ferrite nanoparticles coated with PEG were studied for their potential usefulness in MRI thermometry as temperature-sensitive contrast agents. Particles in the form of an 8.5 nm ...core coated with a 3.5 nm layer of PEG were fabricated using a newly developed, one-step method. The composition of Mn0.48Zn0.46Fe2.06O4 was found to have a strong thermal dependence of magnetization in the temperature range between 5 and 50 °C. Nanoparticles suspended in an agar gel mimicking animal tissue and showing non-significant impact on cell viability in the biological test were studied with NMR and MRI over the same temperature range. For the concentration of 0.017 mg/mL of Fe, the spin–spin relaxation time T2 increased from 3.1 to 8.3 ms, while longitudinal relaxation time T1 shows a moderate decrease from 149.0 to 125.1 ms. A temperature map of the phantom exposed to the radial temperature gradient obtained by heating it with an 808 nm laser was calculated from T2 weighted spin-echo differential MR images. Analysis of temperature maps yields thermal/spatial resolution of 3.2 °C at the distance of 2.9 mm. The experimental relaxation rate R2 data of water protons were compared with those obtained from calculations using a theoretical model incorporating the motion averaging regime.
Objective To evaluate by magnetic resonance imaging the physical effects of convective thermal energy transfer with water vapor as a means of treating lower urinary tract symptoms due to benign ...prostatic hyperplasia. Methods Sixty-five men with lower urinary tract symptoms were treated with the Rezūm System by transurethral intraprostatic injection of water vapor. A group of 45 of these men consented to undergo a series of gadolinium-enhanced magnetic resonance imagings of the prostate after treatment to monitor the size and location of ablative lesions, their time course of resolution, and the corresponding change in prostate tissue volume. Visualization was conducted at 1 week, 1, 3, and 6 months after treatment. Results Outcomes were available for 44 patients. Convective thermal lesions were limited to the transition zone and correlated with targeted treatment locations. At 1 week after treatment, the mean volume of ablative lesions was 8.2 cm3 (0.5-24.0 cm3 ). At 6 months, whole prostate volume was reduced by a mean of 28.9% and transition zone volume by 38.0% as compared with baseline 1-week images. At 3 and 6 months after treatment, the lesion volumes had reduced by 91.5% and 95.1%, respectively. Lesions remained within the targeted treatment zone without compromising integrity of the bladder, rectum, or striated urinary sphincter. Conclusion This imaging study confirms the delivery of convective water vapor technology to create thermal lesions in the prostate tissue. Lesions generated underwent near complete resolution by 3 and 6 months after treatment with a concomitant one-third reduction in overall prostate and transition zone volumes.
To assess the feasibility, safety and local tumor control of cryoablation for treatment of pulmonary metastases.
This Health Insurance Portability and Accountability Act (HIPAA) compliant, ...IRB-approved, multicenter, prospective, single arm study included 40 patients with 60 lung metastases treated during 48 cryoablation sessions, with currently a minimum of 12 months of follow-up. Patients were enrolled according to the following key inclusion criteria: 1 to 5 metastases from extrapulmonary cancers, with a maximal diameter of 3.5 cm. Local tumor control, disease-specific and overall survival rates were estimated using the Kaplan–Meier method. Complications and changes in physical function and quality of life were also evaluated using Karnofsky performance scale, Eastern Cooperative Oncology Group performance status classification, and Short Form-12 health survey.
Patients were 62.6 ± 13.3 years old (26–83). The most common primary cancers were colon (40%), kidney (23%), and sarcomas (8%). Mean size of metastases was 1.4 ± 0.7 cm (0.3–3.4), and metastases were bilateral in 20% of patients. Cryoablation was performed under general anesthesia (67%) or conscious sedation (33%). Local tumor control rates were 56 of 58 (96.6%) and 49 of 52 (94.2%) at 6 and 12 months, respectively. Patient's quality of life was unchanged over the follow-up period. One-year overall survival rate was 97.5%. The rate of pneumothorax requiring chest tube insertion was 18.8%. There were three Common Terminology Criteria for Adverse Events grade 3 procedural complications during the immediate follow-up period (pneumothorax requiring pleurodesis, noncardiac chest pain, and thrombosis of an arteriovenous fistula), with no grade 4 or 5 complications.
Cryoablation is a safe and effective treatment for pulmonary metastases with preserved quality of life following intervention.
To assess the safety and effectiveness of percutaneous cryoablation to treat limited metastases to the musculoskeletal system, with the goal of complete disease remission.
In a single-institution ...retrospective study of data from December 2003 to October 2011, 43 consecutive patients underwent initial cryoablation of limited (five or fewer) musculoskeletal metastases with the goal of complete disease remission (ie, no clinical or radiographic evidence of disease). Three patients were lost to follow-up. As a result, the present report describes 40 patients who underwent 40 cryoablation procedures to treat 52 tumors.
Local control was achieved in 45 of 52 tumors (87%; 95% confidence interval CI, 75%-93%) at a median follow-up of 21 months (range, 4-62 mo). Thirteen of 19 treated bone metastases (68%) and 32 of 33 soft-tissue metastases (97%) showed local control (P = .007). One- and 2-year overall survival rates were 91% (95% CI, 75%-97%) and 84% (95% CI, 65%-93%), respectively. Median overall survival was 47 months (95% CI, 26-62 mo). One- and 2-year disease-free survival rates were 22% (95% CI, 11%-37%) and 7% (95% CI,<1% to 26%), respectively. Median disease-free survival was 7 months (95% CI, 5-10 mo). Two of 40 procedures (5%) were associated with major complications.
Percutaneous cryoablation is a safe and effective treatment to achieve local tumor control and short-term complete disease remission in patients with limited metastatic disease to the musculoskeletal system.
Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30–50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek ...uterine-preserving treatments, but comparative effectiveness trials are lacking.
The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging–guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study.
The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging–guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function.
From 2010–2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging–guided focused ultrasound surgery 27 randomized; 40 for uterine artery embolization 22 randomized); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging–guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01–7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging–guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention.
Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention. Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov
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