Purpose: This paper presents the design of a micro‐CT guided small animal robotic needle positioning system. In order to simplify the robotic design and maintain a small targeting error, a novel implementation of the remote center of motion is used in the system. The system has been developed with the objective of achieving a mean targeting error of <200 μm while maintaining a high degree of user friendliness. Methods: The robot is compact enough to operate within a 25 cm diameter micro‐CT bore. Small animals can be imaged and an intervention performed without the need to transport the animal from one workspace to another. Not requiring transport of the animal reduces opportunities for targets to shift from their localized position in the image and simplifies the workflow of interventions. An improved method of needle calibration is presented that better characterizes the calibration using the position of the needle tip in photographs rather than the needle axis. A calibration fixture was also introduced, which dramatically reduces the time requirements of calibration while maintaining calibration accuracy. Two registration modes have been developed to correspond the robot coordinate system with the coordinate system of the micro‐CT scanner. The two registration modes offer a balance between the time required to complete a registration and the overall registration accuracy. The development of slow high accuracy and fast low accuracy registration modes provides users with a degree of flexibility in selecting a registration mode best suited for their application. Results: The target registration error (TRE) of the higher accuracy primary registration was TRE primary = 31 ± 12 μm. The error in the lower accuracy combined registration was TRE combined = 139 ± 63 μm. Both registration modes are therefore suitable for small‐animal needle interventions. The targeting accuracy of the robotic system was characterized using targeting experiments in tissue‐mimicking gelatin phantoms. The results of the targeting experiments were combined with the known calibration and needle deflection errors to provide a more meaningful measure of the needle positioning accuracy of the system. The combined targeting errors of the system were 149 ± 41 μm and 218 ± 38 μm using the primary and combined registrations, respectively. Finally, pilot in vivo experiments were successfully completed to demonstrate the performance of the system in a biomedical application. Conclusions: The device was able to achieve the desired performance with an error of <200 μm and improved repeatability when compared to other designs. The device expands the capabilities of image‐guided interventions for preclinical biomedical applications.
In this study, we propose combining three-dimensional (3D) transrectal ultrasound (TRUS) and 3D transabdominal ultrasound (TAUS) images of gynecologic brachytherapy applicators to leverage the advantages of each imaging perspective, providing a broader field-of-view and allowing previously obscured features to be recovered. The aim of this study was to evaluate the feasibility of fusing these 3D ultrasound (US) perspectives based on the applicator geometry in a phantom prior to clinical implementation.In proof-of-concept experiments, 3D US images of application-specific multimodality pelvic phantoms were acquired with tandem-and-ring and tandem-and-ovoids applicators using previously validated imaging systems. Two TRUS images were acquired at different insertion depths and manually fused based on the position of the ring/ovoids to broaden the TRUS field-of-view. The phantom design allowed "abdominal thickness" to be modified to represent different body habitus and TAUS images were acquired at three thicknesses for each applicator. The merged TRUS images were then combined with TAUS images by rigidly aligning applicator components and manually refining the registration using the positions of source channels and known tandem length, as well as the ring diameter for the tandem-and-ring applicator. Combined 3D US images were manually, rigidly registered to images from a second modality (magnetic resonance (MR) imaging for the tandem-and-ring applicator and X-ray computed tomography (CT) for the tandem-and-ovoids applicator (based on applicator compatibility)) to assess alignment. Four spherical fiducials were used to calculate target registration errors (TREs), providing a metric for validating registrations, where TREs were computed using root-mean-square distances to describe the alignment of manually identified corresponding fiducials. An analysis of variance (ANOVA) was used to identify statistically significant differences (p < 0.05) between the TREs for the three abdominal thicknesses for each applicator type. As an additional indicator of geometric accuracy, the bladder was segmented in the 3D US and corresponding MR/CT images, and volumetric differences and Dice similarity coefficients (DSCs) were calculated.For both applicator types, the combination of 3D TRUS with 3D TAUS images allowed image information obscured by the shadowing artifacts under single imaging perspectives to be recovered. For the tandem-and-ring applicator, the mean ± one standard deviation (SD) TREs from the images with increasing thicknesses were 1.37 ± 1.35 mm, 1.84 ± 1.22 mm, and 1.60 ± 1.00 mm. Similarly, for the tandem-and-ovoids applicator, the mean ± SD TREs from the images with increasing thicknesses were 1.37 ± 0.35 mm, 1.95 ± 0.90 mm, and 1.61 ± 0.76 mm. No statistically significant difference was detected in the TREs for the three thicknesses for either applicator type. The mean volume differences for the bladder segmentations were 3.14% and 2.33% and mean DSCs were 87.8% and 87.7% for the tandem-and-ring and tandem-and-ovoids applicators, respectively.In this proof-of-concept study, we demonstrated the feasibility of fusing 3D TRUS and 3D TAUS images based on the geometry of tandem-and-ring and tandem-and-ovoids applicators. This represents a step toward an accessible and low-cost 3D imaging method for gynecologic brachytherapy, with the potential to extend this approach to other intracavitary configurations and hybrid applicators.
Multiparametric MRI (mpMRI) is an effective tool for detecting and staging prostate cancer (PCa), guiding interventional therapy, and monitoring PCa treatment outcomes. MRI-guided focal laser ablation (FLA) therapy is an alternative, minimally invasive treatment method to conventional therapies, which has been demonstrated to control low-grade, localized PCa while preserving patient quality of life. The therapeutic success of FLA depends on the accurate placement of needles for adequate delivery of ablative energy to the target lesion. We previously developed an MR-compatible mechatronic system for prostate FLA needle guidance and validated its performance in open-air and clinical 3T in-bore experiments using virtual targets.To develop a robust MRI-to-mechatronic system registration method and evaluate its in-bore MR-guided needle delivery accuracy in tissue-mimicking prostate phantoms.The improved registration multifiducial assembly houses thirty-six aqueous gadolinium-filled spheres distributed over a 7.3 × 7.3 × 5.2 cm volume. MRI-guided needle guidance accuracy was quantified in agar-based tissue-mimicking prostate phantoms on trajectories (N = 44) to virtual targets covering the mechatronic system's range of motion. 3T gradient-echo recalled (GRE) MRI images were acquired after needle insertions to each target, and the air-filled needle tracks were segmented. Needle guidance error was measured as the shortest Euclidean distance between the target point and the segmented needle trajectory, and angular error was measured as the angle between the targeted trajectory and the segmented needle trajectory. These measurements were made using both the previously designed four-sphere registration fiducial assembly on trajectories (N = 7) and compared with the improved multifiducial assembly using a Mann-Whitney U test.The median needle guidance error of the system using the improved registration fiducial assembly at a depth of 10 cm was 1.02 mm with an interquartile range (IQR) of 0.42-2.94 mm. The upper limit of the one-sided 95% prediction interval of needle guidance error was 4.13 mm. The median (IQR) angular error was 0.0097 rad (0.0057-0.015 rad) with a one-sided 95% prediction interval upper limit of 0.022 rad. The median (IQR) positioning error using the previous four-sphere registration fiducial assembly was 1.87 mm (1.77-2.14 mm). This was found to be significantly different (p = 0.0012) from the median (IQR) positioning error of 0.28 mm (0.14-0.95 mm) using the new registration fiducial assembly on the same trajectories. No significant difference was detected between the medians of the angular errors (p = 0.26).This is the first study presenting an improved registration method and validation in tissue-mimicking phantoms of our remotely actuated MR-compatible mechatronic system for delivery of prostate FLA needles. Accounting for the effects of needle deflection, the system was demonstrated to be capable of needle delivery with an error of 4.13 mm or less in 95% of cases under ideal conditions, which is a statistically significant improvement over the previous method. The system will next be validated in a clinical setting.
High dose-rate brachytherapy is a typical part of the treatment process for cervical cancer. During this procedure, radioactive sources are placed locally to the malignancy using specialized applicators or interstitial needles. To ensure accurate dose delivery and positive patient outcomes, medical imaging is utilized intra-procedurally to ensure precise placement of the applicator. Previously, the fusion of three-dimensional ultrasound images has been investigated as an alternative volumetric imaging technique during cervical brachytherapy treatments. However, the need to manually register the two three-dimensional ultrasound images offline resulted in excessively large registration errors. To overcome this limitation, we have designed and developed a tracked, automated mechatronic system to inherently register three-dimensional ultrasound images in real-time. We perform a system calibration using an external coordinate system transform and validate the system tracking using a commercial optical tracker. The results of both experiments indicated sub-millimeter system accuracy, indicating the superior performance of our device. Future work for this study includes performing phantom validation experiments and translating our device into clinical work.
Purpose: To demonstrate the capabilities of a new magnetic resonance imaging (MRI)‐guided system for delivering needles to the prostate for focal therapy. Included is a presentation of the design of the system and its user interface, evaluation of MR‐compatibility, and quantitative evaluation of guidance accuracy and repeatability within the bore of a clinical MRI scanner. Methods: The use of MRI for visualization of tumors, intraoperative visualization of interventional tools, and thermometry for controlled ablation of lesions is becoming increasingly prevalent. In this work, the authors present a prototype system for guiding needles to prostate tumors within the bore of an MRI scanner for use in focal laser thermal ablation of prostate tumors. The system consists of a manually actuated trajectory alignment device that allows a physician to precisely align a set of needle guides with an intended target in the prostate within the bore of a clinical closed‐bore MRI scanner. Needle insertion is then performed transperineally, with the patient in the bore of the MRI, and custom software provides monitoring of thermal ablative procedures. Results: The system is shown to have a minimal effect on image distortion, and only a 6% decrease in image signal‐to‐noise ratio. Through needle insertion tests in tissue‐mimicking phantoms, the system's potential for reliably guiding needles to intra‐MR targets within 2.64 mm has been demonstrated. Use of the system to deliver focal laser ablation therapy to two patients showed that it can be used to deliver needles with minimal disruption of workflow, and in less time than when insertions are performed freehand or with a fixed grid template. Conclusions: A system for delivering needles to a patient's prostate for focal therapy within the bore of an MRI scanner has been developed. Results from needle insertion tests in phantoms suggest that the system has the potential to provide accurate delivery of focal therapy to prostate tumors of the smallest clinically significant size. Initial tests in two patients showed that needle deflection was larger than in phantoms, but methods of manually compensating for this effect were employed and needles were delivered to treatment sites with sufficient accuracy to deliver effective treatment. In addition, the treatment was delivered in less time than with a fixed grid template or freehand insertions. Despite this success, methods of reducing needle deflection are needed in order to fully utilize the potential of this system, and further reduce total procedure time.
Mammographic screening has reduced mortality in women through the early detection of breast cancer. However, the sensitivity for breast cancer detection is significantly reduced in women with dense breasts, in addition to being an independent risk factor. Ultrasound (US) has been proven effective in detecting small, early-stage, and invasive cancers in women with dense breasts.To develop an alternative, versatile, and cost-effective spatially tracked three-dimensional (3D) US system for whole-breast imaging. This paper describes the design, development, and validation of the spatially tracked 3DUS system, including its components for spatial tracking, multi-image registration and fusion, feasibility for whole-breast 3DUS imaging and multi-planar visualization in tissue-mimicking phantoms, and a proof-of-concept healthy volunteer study.The spatially tracked 3DUS system contains (a) a six-axis manipulator and counterbalanced stabilizer, (b) an in-house quick-release 3DUS scanner, adaptable to any commercially available US system, and removable, allowing for handheld 3DUS acquisition and two-dimensional US imaging, and (c) custom software for 3D tracking, 3DUS reconstruction, visualization, and spatial-based multi-image registration and fusion of 3DUS images for whole-breast imaging. Spatial tracking of the 3D position and orientation of the system and its joints (J1-6 ) were evaluated in a clinically accessible workspace for bedside point-of-care (POC) imaging. Multi-image registration and fusion of acquired 3DUS images were assessed with a quadrants-based protocol in tissue-mimicking phantoms and the target registration error (TRE) was quantified. Whole-breast 3DUS imaging and multi-planar visualization were evaluated with a tissue-mimicking breast phantom. Feasibility for spatially tracked whole-breast 3DUS imaging was assessed in a proof-of-concept healthy male and female volunteer study.Mean tracking errors were 0.87 ± 0.52, 0.70 ± 0.46, 0.53 ± 0.48, 0.34 ± 0.32, 0.43 ± 0.28, and 0.78 ± 0.54 mm for joints J1-6 , respectively. Lookup table (LUT) corrections minimized the error in joints J1 , J2 , and J5 . Compound motions exercising all joints simultaneously resulted in a mean tracking error of 1.08 ± 0.88 mm (N = 20) within the overall workspace for bedside 3DUS imaging. Multi-image registration and fusion of two acquired 3DUS images resulted in a mean TRE of 1.28 ± 0.10 mm. Whole-breast 3DUS imaging and multi-planar visualization in axial, sagittal, and coronal views were demonstrated with the tissue-mimicking breast phantom. The feasibility of the whole-breast 3DUS approach was demonstrated in healthy male and female volunteers. In the male volunteer, the high-resolution whole-breast 3DUS acquisition protocol was optimized without the added complexities of curvature and tissue deformations. With small post-acquisition corrections for motion, whole-breast 3DUS imaging was performed on the healthy female volunteer showing relevant anatomical structures and details.Our spatially tracked 3DUS system shows potential utility as an alternative, accurate, and feasible whole-breast approach with the capability for bedside POC imaging. Future work is focused on reducing misregistration errors due to motion and tissue deformations, to develop a robust spatially tracked whole-breast 3DUS acquisition protocol, then exploring its clinical utility for screening high-risk women with dense breasts.
Prostate cancer is the most frequently diagnosed non-cutaneous cancer and the second leading cause of cancer-related deaths in men. Whole gland surgical and radiation treatments for prostate cancer are highly effective for long-term cancer control. However, these are often associated with overtreatment, resulting in urinary complications and sexual dysfunction, adversely impacting the quality of life. Focal laser ablation (FLA) under magnetic resonance imaging (MRI)-guidance is an alternative minimally invasive treatment method for localized prostate tumors while preserving surrounding structures and healthy tissues. Accurate needle positioning and delivery are critical for the therapeutic success of MRI-guided FLA. We propose an MRI-compatible mechatronic system for in-bore transperineal FLA needle guidance to localized prostate lesions. This paper presents the mechatronic system design, including a remotely actuated, four degree-of-freedom transperineal positioning and needle guidance mechanism, and adaptable needle guide. We demonstrate its MR compatibility and evaluated its mechanical bias in free-space testing using an external optical tracking system with several measurement points (N=40) over its range-of-motion. Free-space testing resulted in a root-mean-square error of 0.71 ± 0.30 mm. Within an MR environment, in-bore testing to virtual targets (N=10) with projected needle trajectories resulted in a mean needle tip error of 1.81 ± 0.56 mm and needle trajectory error of 0.78 ± 0.75°. This suggests that localized ablation regions can be accurately targeted within 2.16 mm within 95% confidence. An extensive in-bore analysis and correction for systematic bias across the range-of-motion may improve this accuracy. This study shows that our proposed mechatronic needle guidance system may be a feasible alternative for accurate MR-guided FLA for localized prostate therapy.
Prostate biopsy procedures are currently limited to using 2D transrectal ultrasound (TRUS) imaging to guide the biopsy needle. Being limited to 2D causes ambiguity in needle guidance and provides an insufficient record to allow guidance to the same suspicious locations or avoid regions that are negative during previous biopsy sessions. We have developed a mechanically assisted 3D ultrasound imaging and needle tracking system, which supports a commercially available TRUS probe and integrated needle guide for prostate biopsy. The mechanical device is fixed to a cart and the mechanical tracking linkage allows its joints to be manually manipulated while fully supporting the weight of the ultrasound probe. The computer interface is provided in order to track the needle trajectory and display its path on a corresponding 3D TRUS image, allowing the physician to aim the needle-guide at predefined targets within the prostate. The system has been designed for use with several end-fired transducers that can be rotated about the longitudinal axis of the probe in order to generate 3D image for 3D navigation. Using the system, 3D TRUS prostate images can be generated in approximately 10 seconds. The system reduces most of the user variability from conventional hand-held probes, which make them unsuitable for precision biopsy, while preserving some of the user familiarity and procedural workflow. In this paper, we describe the 3D TRUS guided biopsy system and report on the initial clinical use of this system for prostate biopsy.
