Intraurethral Ultrasound Thermal Ablation Device with Real-time MRI Guidance 'PAD-105' Pre-clinical Canine Study
CUA Online Library. Billia M. 06/22/13; 31450; UP-71
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Abstract
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Introduction and Objectives: Minimally invasive prostate cancer therapies are gaining attention. Conventional thermal therapies for prostate cancer (PCa) do not provide real-time monitoring of the thermal effects of treatment on tissues, which can impact on therapeutic as well as adverse effects. The aim of this study is to assess a transurethral prostate thermal therapy device coupled with real-time monitoring, in a canine model.
Methods: MRI-guided transurethral ultrasound therapy (Prostate Ablation Device – PAD105) was used to ablate the prostate in 8 dogs. PAD-105 probe can generate a temperature of 50-90°C in tissues. We used the “Dice Similarity Coefficient” (DSC) to evaluate the ability of PAD-105 to generate targeted regions of thermal damage in the prostate under active MRI temperature control. All animals received a perineal urethrostomy prior to the treatment and were clinically followed for 4 weeks. In order to assess the accuracy of the device we correlated the histology features with real-time measurements. Endpoints of the study were: feasibility of the therapy, safety and effect on bowel and urinary function.
Results: No significant side effects or anatomical damage was observed. Mean over-targeted and under-targeted volume was 1% (CI 0-2%) and 10% (CI 3-17), respectively. The targeting accuracy according to DSC was 0.87 (CI=0.82-0.93) for the entire population. Histology analysis confirmed the presence of necrosis limited to the prostate and matched the MRI thermometry measurement in all cases. In one case we observed a major technical failure that resulted in under-targeting of 34.7% and necessitated cessation of the treatment prematurely.
Conclusions: MRI-guided transurethral ultrasound prostate ablation using PAD-105 is a feasible and safe treatment. PAD-105 is able to produce reliable and accurate tissue damage, based on temperature feedback control and final histology specimens. PAD 105 is a promising minimally invasive modality for prostate cancer in a canine model.Clinical evaluation is underway.
Methods: MRI-guided transurethral ultrasound therapy (Prostate Ablation Device – PAD105) was used to ablate the prostate in 8 dogs. PAD-105 probe can generate a temperature of 50-90°C in tissues. We used the “Dice Similarity Coefficient” (DSC) to evaluate the ability of PAD-105 to generate targeted regions of thermal damage in the prostate under active MRI temperature control. All animals received a perineal urethrostomy prior to the treatment and were clinically followed for 4 weeks. In order to assess the accuracy of the device we correlated the histology features with real-time measurements. Endpoints of the study were: feasibility of the therapy, safety and effect on bowel and urinary function.
Results: No significant side effects or anatomical damage was observed. Mean over-targeted and under-targeted volume was 1% (CI 0-2%) and 10% (CI 3-17), respectively. The targeting accuracy according to DSC was 0.87 (CI=0.82-0.93) for the entire population. Histology analysis confirmed the presence of necrosis limited to the prostate and matched the MRI thermometry measurement in all cases. In one case we observed a major technical failure that resulted in under-targeting of 34.7% and necessitated cessation of the treatment prematurely.
Conclusions: MRI-guided transurethral ultrasound prostate ablation using PAD-105 is a feasible and safe treatment. PAD-105 is able to produce reliable and accurate tissue damage, based on temperature feedback control and final histology specimens. PAD 105 is a promising minimally invasive modality for prostate cancer in a canine model.Clinical evaluation is underway.
Introduction and Objectives: Minimally invasive prostate cancer therapies are gaining attention. Conventional thermal therapies for prostate cancer (PCa) do not provide real-time monitoring of the thermal effects of treatment on tissues, which can impact on therapeutic as well as adverse effects. The aim of this study is to assess a transurethral prostate thermal therapy device coupled with real-time monitoring, in a canine model.
Methods: MRI-guided transurethral ultrasound therapy (Prostate Ablation Device – PAD105) was used to ablate the prostate in 8 dogs. PAD-105 probe can generate a temperature of 50-90°C in tissues. We used the “Dice Similarity Coefficient” (DSC) to evaluate the ability of PAD-105 to generate targeted regions of thermal damage in the prostate under active MRI temperature control. All animals received a perineal urethrostomy prior to the treatment and were clinically followed for 4 weeks. In order to assess the accuracy of the device we correlated the histology features with real-time measurements. Endpoints of the study were: feasibility of the therapy, safety and effect on bowel and urinary function.
Results: No significant side effects or anatomical damage was observed. Mean over-targeted and under-targeted volume was 1% (CI 0-2%) and 10% (CI 3-17), respectively. The targeting accuracy according to DSC was 0.87 (CI=0.82-0.93) for the entire population. Histology analysis confirmed the presence of necrosis limited to the prostate and matched the MRI thermometry measurement in all cases. In one case we observed a major technical failure that resulted in under-targeting of 34.7% and necessitated cessation of the treatment prematurely.
Conclusions: MRI-guided transurethral ultrasound prostate ablation using PAD-105 is a feasible and safe treatment. PAD-105 is able to produce reliable and accurate tissue damage, based on temperature feedback control and final histology specimens. PAD 105 is a promising minimally invasive modality for prostate cancer in a canine model.Clinical evaluation is underway.
Methods: MRI-guided transurethral ultrasound therapy (Prostate Ablation Device – PAD105) was used to ablate the prostate in 8 dogs. PAD-105 probe can generate a temperature of 50-90°C in tissues. We used the “Dice Similarity Coefficient” (DSC) to evaluate the ability of PAD-105 to generate targeted regions of thermal damage in the prostate under active MRI temperature control. All animals received a perineal urethrostomy prior to the treatment and were clinically followed for 4 weeks. In order to assess the accuracy of the device we correlated the histology features with real-time measurements. Endpoints of the study were: feasibility of the therapy, safety and effect on bowel and urinary function.
Results: No significant side effects or anatomical damage was observed. Mean over-targeted and under-targeted volume was 1% (CI 0-2%) and 10% (CI 3-17), respectively. The targeting accuracy according to DSC was 0.87 (CI=0.82-0.93) for the entire population. Histology analysis confirmed the presence of necrosis limited to the prostate and matched the MRI thermometry measurement in all cases. In one case we observed a major technical failure that resulted in under-targeting of 34.7% and necessitated cessation of the treatment prematurely.
Conclusions: MRI-guided transurethral ultrasound prostate ablation using PAD-105 is a feasible and safe treatment. PAD-105 is able to produce reliable and accurate tissue damage, based on temperature feedback control and final histology specimens. PAD 105 is a promising minimally invasive modality for prostate cancer in a canine model.Clinical evaluation is underway.
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