Hybrid TRUS/CT with optical tracking for target delineation in image-guided adaptive brachytherapy for cervical cancer.

OBJECTIVE: To prospectively compare the interobserver variability of combined transrectal ultrasound (TRUS)/computed tomography (CT)- vs. CT only- vs. magnetic resonance imaging (MRI) only-based contouring of the high-risk clinical target volume (CTVHR) in image-guided adaptive brachytherapy (IGABT) for locally advanced cervical cancer (LACC). METHODS: Five patients with LACC (FIGO stages IIb-IVa) treated with radiochemotherapy and IGABT were included. CT, TRUS, and T2-weighted MRI images were performed after brachytherapy applicator insertion. 3D-TRUS image acquisition was performed with a customized ultrasound stepper device and software. Automatic applicator reconstruction using optical tracking was performed in the TRUS dataset and TRUS and CT images were fused with rigid image registration with the applicator as reference structure. The CTVHR (based on the GEC-ESTRO recommendations) was contoured by five investigators on the three modalities (CTVHR_CT, CTVHR_TRUS-CT, and CTVHR_MRI). A consensus reference CTVHR_MRI (MRIref) was defined for each patient. Descriptive statistics and overlap measures were calculated using RTslicer (SlicerRT Community and Percutaneous Surgery Laboratory, Queen's University, Canada), comparing contours of every observer with one another and with the MRIref. RESULTS: The interobserver coefficient of variation was 0.18 ± 0.05 for CT, 0.10 ± 0.04 for TRUS-CT, and 0.07 ± 0.03 for MRI. Interobserver concordance in relation to the MRIref expressed by the generalized conformity index was 0.75 ± 0.04 for MRI, 0.51 ± 0.10 for TRUS-CT, and 0.48 ± 0.06 for CT. The mean CTVHR_CT volume of all observers was 71% larger than the MRIref volume, whereas the mean CTVHR_TRUS-CT volume was 15% larger. CONCLUSION: Hybrid TRUS-CT as an imaging modality for contouring the CTVHR in IGABT for LACC is feasible and reproducible among multiple observers. TRUS-CT substantially reduces overestimation of the CTVHR volume of CT alone while maintaining similar interobserver variability.

Robotic systems for percutaneous needle-guided interventions.

Several groups have developed robotic systems for invasive medical procedures. In this article we will focus on selected robotic systems for percutaneous needle-guided interventions using CT or MR imaging. We present six interventional robotic systems designed to work with imaging modalities such as CT, Cone-beam CT and MRI. The details of each system are given along with any phantom, animal, or human trials performed with each particular robot. Although each of these systems has specific features, they are all of great clinical value since they provide very stable needle guidance -- even for angulated approaches, they may allow access to lesions when the width of the CT- or MR- gantry would limit the access for a biopsy needle or other interventional tools such as thermal ablation probes. Then, such a robot may be able to guide the needle into the most promising region of the lesion without the need for a second contrast injection. Thus, more efficacious characterization and treatment, particularly for lesions that are difficult to target, can be anticipated. Although more research and clinical trials are certainly needed, it is, however, our belief that robotic systems will be an important part of future interventions.

Robotic natural orifice transluminal endoscopic surgery (R-NOTES): literature review and prototype system.

In minimally invasive surgery methods such as laparoscopic surgery, surgical instruments are introduced through small incisions to minimize patient trauma and recovery times. To reduce the number of incisions, new techniques such as natural orifice transluminal endoscopic surgery (NOTES) have been proposed. Compared to laparoscopic surgery, the NOTES approach, which requires new technology and improved instruments, presents some unique challenges. Robotic NOTES (R-NOTES) could be an enabling technology for these procedures. In this paper, we first review relevant work in R-NOTES. We then present our work and the system architecture for an R-NOTES prototype system incorporating wireless command and control. The system was tested twice in swine animal studies.

Virtobot 2.0: the future of automated surface documentation and CT-guided needle placement in forensic medicine.

In this paper we present the second prototype of a robotic system to be used in forensic medicine. The system is capable of performing automated surface documentation using photogrammetry, optical surface scanning and image-guided, post-mortem needle placement for tissue sampling, liquid sampling, or the placement of guide wires. The upgraded system includes workflow optimizations, an automatic tool-change mechanism, a new software module for trajectory planning and a fully automatic computed tomography-data-set registration algorithm. We tested the placement accuracy of the system by using a needle phantom with radiopaque markers as targets. The system is routinely used for surface documentation and resulted in 24 surface documentations over the course of 11 months. We performed accuracy tests for needle placement using a biopsy phantom, and the Virtobot placed introducer needles with an accuracy of 1.4 mm (±0.9 mm). The second prototype of the Virtobot system is an upgrade of the first prototype but mainly focuses on streamlining the workflow and increasing the level of automation and also has an easier user interface. These upgrades make the Virtobot a potentially valuable tool for case documentation in a scalpel-free setting that uses purely imaging techniques and minimally invasive procedures and is the next step toward the future of virtual autopsy.

A robotic needle-positioning and guidance system for CT-guided puncture: Ex vivo results.

PURPOSE: To test the feasibility of a robotic needle-guidance platform during CT-guided puncture ex vivo. MATERIAL AND METHODS: Thin copper wires inserted into a torso phantom served as targets. The phantom was placed on a carbon plate and the robot-positioning unit (RPU) of the guidance platform (iSYS Medizintechnik GmbH, Kitzbuehel, Austria) was attached. Following CT imaging and automatic registration a double oblique trajectory was planned and the RPU was remotely moved into appropriate position and angulation. A 17G-puncture needle was then manually inserted until the preplanned depth, permanently guided by the RPU. The CT scan was repeated and the distance between the actual needle tip and the target was evaluated. RESULTS: Automatic registration was successful in ten experiments and the median duration of an experiment was 9.6 (6.4-46.0) minutes. The angulation of the needle path in x-y and z-axis was within 15.6° to 32.6°, and -32.8° to 3.2°, respectively and the needle insertion depth was 92.8 ± 14.4 mm. The Euclidean distance between the actual needle tip and the target was 2.3 ± 0.8 (range, 0.9-3.7) mm. CONCLUSION: Automatic registration and accurate needle placement close to small targets was demonstrated. Study settings and torso phantom were very close to the clinical reality.

Intra-fractional lung tumor motion monitoring using arbitrary gantry angles during radiotherapy treatment.

Intensity-based 2D/3D registration using kilo-voltage (kV) and mega-voltage (MV) on-board imaging is a promising approach for real-time tumor motion tracking. So far, the performance of the kV images as well as kV-MV image pairs for 2D/3D registration using only one gantry angle (in anterior-posterior (AP) direction) has been investigated on patient data. In stereotactic body radiation therapy (SBRT), however, various gantry angles are typically used. This study attempts to answer the question of whether automatic 2D/3D registration is possible using kV images as well as kV-MV image pairs for gantry angles other than the AP direction. We also investigated the effect of additional portal MV images paired with kV images to improve 2D/3D registration in extracting cranio-caudal (CC) and AP displacement at arbitrary gantry angles and different fractions. The kV and MV image sequences as well as 3D volume data from five patients suffering from non-small cell lung cancer undergoing SBRT were used. Diaphragm motion served as the reference signal. The CC and AP displacements resulting from the registration results were compared with the corresponding reference motion signal. Pearson correlation coefficients (R value) was used to calculate the similarity measure between reference signal and the extracted displacements resulting from the registration. Signals we found that using 2D/3D registration tumor motion in 5 degrees of freedom (DOF) with kV images and in 6 degrees of freedom with kV-MV image pairs can be extracted for most gantry angles in all patients. Furthermore, our results have shown that the use of kV-MV image pairs increases the overall chance of tumor visibility and therefore leads to more successful extraction of CC as well as AP displacements for almost all gantry angles in all patients. We observed an improvement in registration of at least 0.29% more gantry angle for all patients when we used kV-MV images compared to kV images alone. In addition, an improvement in the R-value was observed in up to 16 fractions in various patients.

Source-detector trajectory optimization for CBCT metal artifact reduction based on PICCS reconstruction.

Precise instrument placement plays a critical role in all interventional procedures, especially percutaneous procedures such as needle biopsies, to achieve successful tumor targeting and increased diagnostic accuracy. C-arm cone beam computed tomography (CBCT) has the potential to precisely visualize the anatomy in direct vicinity of the needle and evaluate the adequacy of needle placement during the intervention, allowing for instantaneous adjustment in case of misplacement. However, even with the most advanced C-arm CBCT devices, it can be difficult to identify the exact needle position on CBCT images due to the strong metal artifacts around the needle. In this study, we proposed a framework for customized trajectory design in CBCT imaging based on Prior Image Constrained Compressed Sensing (PICCS) reconstruction with the goal of reducing metal artifacts in needle-based procedures. We proposed to optimize out-of-plane rotations in three-dimensional (3D) space and minimize projection views while reducing metal artifacts at specific volume of interests (VOIs). An anthropomorphic thorax phantom with a needle inserted inside and two tumor models as the imaging targets were used to validate the proposed approach. The performance of the proposed approach was also evaluated for CBCT imaging under kinematic constraints by simulating some collision areas on the geometry of the C-arm. We compared the result of optimized 3D trajectories using the PICCS algorithm and 20 projections with the result of a circular trajectory with sparse view using PICCS and Feldkamp, Davis, and Kress (FDK), both using 20 projections, and the circular FDK method with 313 projections. For imaging targets 1 and 2, the highest values of structural similarity index measure (SSIM) and universal quality index (UQI) between the reconstructed image from the optimized trajectories and the initial CBCT image at the VOI was calculated 0.7521, 0.7308 and 0.7308, 0.7248 respectively. These results significantly outperformed the FDK method (with 20 and 313 projections) and the PICCS method (20 projections) both using the circular trajectory. Our results showed that the proposed optimized trajectories not only significantly reduce metal artifacts but also suggest a dose reduction for needle-based CBCT interventions, considering the small number of projections used. Furthermore, our results showed that the optimized trajectories are compatible with spatially constrained situations and enable CBCT imaging under kinematic constraints when the standard circular trajectory is not feasible.

Silicone phantoms fabricated with multi-material extrusion 3D printing technology mimicking imaging properties of soft tissues in CT.

Recently, 3D printing has been widely used to fabricate medical imaging phantoms. So far, various rigid 3D printable materials have been investigated for their radiological properties and efficiency in imaging phantom fabrication. However, flexible, soft tissue materials are also needed for imaging phantoms for simulating several clinical scenarios where anatomical deformations is important. Recently, various additive manufacturing technologies have been used to produce anatomical models based on extrusion techniques that allow the fabrication of soft tissue materials. To date, there is no systematic study in the literature investigating the radiological properties of silicone rubber materials/fluids for imaging phantoms fabricated directly by extrusion using 3D printing techniques. The aim of this study was to investigate the radiological properties of 3D printed phantoms made of silicone in CT imaging. To achieve this goal, the radiodensity as described as Hounsfield Units (HUs) of several samples composed of three different silicone printing materials were evaluated by changing the infill density to adjust their radiological properties. A comparison of HU values with a Gammex Tissue Characterization Phantom was performed. In addition, a reproducibility analysis was performed by creating several replicas for specific infill densities. A scaled down anatomical model derived from an abdominal CT was also fabricated and the resulting HU values were evaluated. For the three different silicone materials, a spectrum ranging from -639 to +780 HU was obtained on CT at a scan setting of 120 kVp. In addition, using different infill densities, the printed materials were able to achieve a similar radiodensity range as obtained in different tissue-equivalent inserts in the Gammex phantom (238 HU to -673 HU). The reproducibility results showed good agreement between the HU values of the replicas compared to the original samples, confirming the reproducibility of the printed materials. A good agreement was observed between the HU target values in abdominal CT and the HU values of the 3D-printed anatomical phantom in all tissues.

Additively manufactured test phantoms for mimicking soft tissue radiation attenuation in CBCT using Polyjet technology.

OBJECTIVES: To develop and validate a simple approach for building cost-effective imaging phantoms for Cone Beam Computed Tomography (CBCT) using a modified Polyjet additive manufacturing technology where a single material can mimic a range of human soft-tissue radiation attenuation. MATERIALS AND METHODS: Single material test phantoms using a cubic lattice were designed in 3-Matic 15.0 software . Keeping the individual cubic lattice volume constant, eight different percentage ratio (R) of air: material from 0% to 70% with a 10% increment were assigned to each sample. The phantoms were printed in three materials, namely Vero PureWhite, VeroClear and TangoPlus using Polyjet technology. The CT value analysis, non-contact profile measurement and microCT-based volumetric analysis was performed for all the samples. RESULTS: The printed test phantoms produced a grey value spectrum equivalent to the radiation attenuation of human soft tissues in the range of -757 to +286 HU on CT. The results from dimensional comparison analysis of the printed phantoms with the digital test phantoms using non-contact profile measurement showed a mean accuracy of 99.07 % and that of micro-CT volumetric analysis showed mean volumetric accuracy of 84.80-94.91%. The material and printing costs of developing 24 test phantoms was 83.00 Euro. CONCLUSIONS: The study shows that additive manufacturing-guided macrostructure manipulation modifies successfully the radiographic visibility of a material in CBCT imaging with 1 mm3 resolution, helping customization of imaging phantoms.

3D-Printed multi-material liver model with simultaneous mechanical and radiological tissue-mimicking features for improved realism.

89Anatomic models have an important role in the medical domain. However, soft tissue mechanical properties' representation is limited in mass-produced and 3D-printed models. In this study, a multi-material 3D printer was used to print a human liver model featuring tuned mechanical and radiological properties, with the goal of comparing the printed model with its printing material and real liver tissue. The main target was mechanical realism, while radiological similarity was a secondary objective. Materials and internal structure were selected such that the printed model would resemble liver tissue in terms of tensile properties. The model was printed at 33% scaling and 40% gyroid infill with a soft silicone rubber, and silicone oil as a filler fluid. After printing, the liver model underwent CT scanning. Since the shape of the liver is incompatible with tensile testing, tensile testing specimens were also printed. Three replicates were printed with the same internal structure as the liver model and three more out of silicone rubber with 100% rectilinear infill to allow a comparison. All specimens were tested in a four-step cyclic loading test protocol to compare elastic moduli and dissipated energy ratios. The fluid-filled and full-silicone specimens had initial elastic moduli of 0.26 MPa and 0.37 MPa, respectively, and featured dissipated energy ratios of 0.140, 0.167, 0.183, and 0.118, 0.093, 0.081, respectively, in the second, third, and fourth loading cycles. The liver model showed 225 ± 30 Hounsfield units (HU) in CT, which is closer to real human liver (70 ± 30 HU) than the printing silicone (340 ± 50 HU). Results suggest that the liver model became more realistic in terms of mechanical and radiological properties with the proposed printing approach as opposed to printing only with silicone rubber. Thus, it has been demonstrated that this printing method enables new customization opportunities in the field of anatomic models.

Realistic 3D printed CT imaging tumor phantoms for validation of image processing algorithms.

Medical imaging phantoms are widely used for validation and verification of imaging systems and algorithms in surgical guidance and radiation oncology procedures. Especially, for the performance evaluation of new algorithms in the field of medical imaging, manufactured phantoms need to replicate specific properties of the human body, e.g., tissue morphology and radiological properties. Additive manufacturing (AM) technology provides an inexpensive opportunity for accurate anatomical replication with customization capabilities. In this study, we proposed a simple and cheap protocol using Fused Deposition Modeling (FDM) technology to manufacture realistic tumor phantoms based on the filament 3D printing technology. Tumor phantoms with both homogenous and heterogeneous radiodensity were fabricated. The radiodensity similarity between the printed tumor models and real tumor data from CT images of lung cancer patients was evaluated. Additionally, it was investigated whether a heterogeneity in the 3D printed tumor phantoms as observed in the tumor patient data had an influence on the validation of image registration algorithms. A radiodensity range between -217 to 226 HUs was achieved for 3D printed phantoms using different filament materials; this range of radiation attenuation is also observed in the human lung tumor tissue. The resulted HU range could serve as a lookup-table for researchers and phantom manufactures to create realistic CT tumor phantoms with the desired range of radiodensities. The 3D printed tumor phantoms also precisely replicated real lung tumor patient data regarding morphology and could also include life-like heterogeneity of the radiodensity inside the tumor models. An influence of the heterogeneity on accuracy and robustness of the image registration algorithms was not found.

A Patient-Specific Reference Tracker for Noninvasive Electromagnetic Navigation of Endoscopic Skull Base Surgery.

BACKGROUND: Owing to the possibility of nonrigid head fixation, electromagnetic navigation (EM) is a mainstay for endoscopic skull base surgery. The currently available dynamic reference trackers (RTs) are invasive or inaccurate. OBJECTIVE: To investigate the feasibility and stability of this innovative oral tracker (OT), which is adhesive to the hard palate in comparison with a commercially available skin adhesive tracker (ST). METHODS: A prospective series of 31 patients with intrasellar lesions who underwent surgery between 2019 and 2021 using a pure endoscopic transsphenoidal approach were evaluated. A patient-specific palatal mold was designed from preoperative computed tomography data. The OT was cast using a biocompatible algin with an integrated EM tracker assembly. In comparison with a skull-mounted RT, which served as a gold standard, the deviations of OT vs those of the ST with the RT were continuously assessed. RESULTS: The OT showed significantly lower deviations from the RT than the ST during the surgical steps: start of endoscopic surgery (OT vs ST: 0.62 mm, IQR 0.36-0.89 vs 1.65 mm, IQR 1.35-2.32, P < .001), drilling phase (OT vs ST: 0.81 mm, IQR 0.51-1.32 vs 1.89 mm, IQR 1.6-2.74, P < .001), and end of endoscopic surgery (OT vs ST: 1.1 mm, IQR 0.68-1.64 vs 1.9 mm, IQR 1.6-2.72, P < .001). CONCLUSION: The OT showed significantly higher intraoperative stability than the ST. Therefore, this noninvasive and patient-specific tool could be used to achieve accurate EM guidance during endoscopic skull base surgeries.

Toward 3D-TRUS image-guided interstitial brachytherapy for cervical cancer.

PURPOSE: To qualitatively and quantitatively analyze needle visibility in combined intracavitary and interstitial cervical cancer brachytherapy on 3D transrectal ultrasound (TRUS) in comparison to gold standard MRI. METHODS AND MATERIALS: Image acquisition was done with a customized TRUS stepper unit and software (Medcom, Germany; Elekta, Sweden; ACMIT, Austria) followed by an MRI on the same day with the applicator in place. Qualitative assessment was done with following scoring system: 0 = no visibility 1 (= poor), 2 (= fair), 3 (= excellent) discrimination, quantitative assessment was done by measuring the distance between each needle and the tandem two centimeters (cm) above the ring and comparing to the respective measurement on MRI. RESULTS: Twenty-nine implants and a total of 188 needles (132 straight, 35 oblique, 21 free-hand) were available. Overall, 79% were visible (87% straight, 51% oblique, 76% free-hand). Mean visibility score was 1.4 ± 0.5 for all visible needles. Distance of the visible needles to tandem was mean ± standard deviation (SD) 21.3 millimeters (mm) ± 6.5 mm on MRI and 21.0 mm ± 6.4 mm on TRUS, respectively. Difference between MRI and TRUS was max 14 mm, mean ± SD -0.3 mm ± 2.6 mm. 11% differed more than 3 mm. CONCLUSIONS: Straight needles were better detectable than oblique needles (87% vs. 51%). Detectability was impaired by insufficient rotation of the TRUS probe, poor image quality or anatomic variation. As needles show a rather indistinct signal on TRUS, online detection with a standardized imaging protocol in combination with tracking should be investigated, aiming at the development of real time image guidance and online treatment planning.

Optimizing maximum resection of glioblastoma: Raman spectroscopy versus 5-aminolevulinic acid.

OBJECTIVE: The objective of this study was to assess and compare the potential of 5-aminolevulinic acid (5-ALA) and Raman spectroscopy (RS) in detecting tumor-infiltrated brain in patients with glioblastoma (GBM). METHODS: Between July 2020 and October 2021, the authors conducted a prospective clinical trial with 15 patients who underwent neurosurgical treatment of newly diagnosed and histologically verified GBM. A solid contrast-enhancing tumor core and peritumoral tissue were investigated intraoperatively for cancer cells by using 5-ALA and RS to achieve pathology-tailored maximum resection. In each case, a minimum of 10 biopsies were sampled from navigation-guided areas. Two neuropathologists examined the biopsies for the presence of neoplastic cells. The detection performance of 5-ALA and RS alone and in combination was assessed. Pre- and postoperative MRI, Karnofsky Performance Status (KPS), and National Institutes of Health Stroke Scale (NIHSS) scores were compared, and median progression-free survival (PFS) was evaluated. RESULTS: A total of 185 biopsy samples were harvested from the contrast-enhancing tumor core (n = 19) and peritumoral tissue (n = 166). In the tumor core, 5-ALA and RS each showed a sensitivity of 100%. In the peritumoral tissue, 5-ALA was less sensitive than RS in detecting cancer (46% vs 69%) but showed higher specificity (81% vs 57%). When the two methods were combined, the accuracy of tumor detection was increased by about 10%. Pathology-tailored resection led to a 52% increase in resection volume comparing the volume of preoperative contrast enhancement with the postoperative resection cavity on MRI (p = 0.0123). Eloquent brain involvement prevented gross-total resection in 4 patients. Four weeks after surgery, mean KPS (p = 0.7637) and NIHSS scores (p = 0.3146) were not significantly different from preoperative values. Of the 13 patients who had received postoperative chemoradiotherapy, 4 did not show any progression after a median follow-up of 14 months. The remaining 9 patients had a median PFS of 8 months. CONCLUSIONS: According to the study data, RS is capable of detecting tumor-infiltrated brain with higher sensitivity but lower specificity than the current standard of 5-ALA. With further technological and workflow advancements, RS in combination with protoporphyrin IX fluorescence may contribute to pathology-tailored glioma resection in the future.

3D printed patient-specific thorax phantom with realistic heterogenous bone radiopacity using filament printer technology.

Current medical imaging phantoms are usually limited by simplified geometry and radiographic skeletal homogeneity, which confines their usage for image quality assessment. In order to fabricate realistic imaging phantoms, replication of the entire tissue morphology and the associated CT numbers, defined as Hounsfield Unit (HU) is required. 3D printing is a promising technology for the production of medical imaging phantoms with accurate anatomical replication. So far, the majority of the imaging phantoms using 3D printing technologies tried to mimic the average HU of soft tissue human organs. One important aspect of the anthropomorphic imaging phantoms is also the replication of realistic radiodensities for bone tissues. In this study, we used filament printing technology to develop a CT-derived 3D printed thorax phantom with realistic bone-equivalent radiodensity using only one single commercially available filament. The generated thorax phantom geometry closely resembles a patient and includes direct manufacturing of bone structures while creating life-like heterogeneity within bone tissues. A HU analysis as well as a physical dimensional comparison were performed in order to evaluate the density and geometry agreement between the proposed phantom and the corresponding CT data. With the achieved density range (-482 to 968 HU) we could successfully mimic the realistic radiodensity of the bone marrow as well as the cortical bone for the ribs, vertebral body and dorsal vertebral column in the thorax skeleton. In addition, considering the large radiodensity range achieved a full thorax imaging phantom mimicking also soft tissues can become feasible. The physical dimensional comparison using both Extrema Analysis and Collision Detection methods confirmed a mean surface overlap of 90% and a mean volumetric overlap of 84,56% between the patient and phantom model. Furthermore, the reproducibility analyses revealed a good geometry and radiodensity duplicability in 24 printed cylinder replicas. Thus, according to our results, the proposed additively manufactured anthropomorphic thorax phantom has the potential to be efficiently used for validation of imaging- and radiation-based procedures in precision medicine.

Development of a Multi-Material 3D Printer for Functional Anatomic Models.

Anatomic models are important in medical education and pre-operative planning as they help students or doctors prepare for real scenarios in a risk-free way. Several experimental anatomic models were made with additive manufacturing techniques to improve geometric, radiological, or mechanical realism. However, reproducing the mechanical behavior of soft tissues remains a challenge. To solve this problem, multi-material structuring of soft and hard materials was proposed in this study, and a three-dimensional (3D) printer was built to make such structuring possible. The printer relies on extrusion to deposit certain thermoplastic and silicone rubber materials. Various objects were successfully printed for testing the feasibility of geometric features such as thin walls, infill structuring, overhangs, and multi-material interfaces. Finally, a small medical image-based ribcage model was printed as a proof of concept for anatomic model printing. The features enabled by this printer offer a promising outlook on mimicking the mechanical properties of various soft tissues.

Development of a miniaturized robotic guidance device for stereotactic neurosurgery.

OBJECTIVE: Consistently high accuracy and a straightforward use of stereotactic guidance systems are crucial for precise stereotactic targeting and a short procedural duration. Although robotic guidance systems are widely used, currently available systems do not fully meet the requirements for a stereotactic guidance system that combines the advantages of frameless surgery and robotic technology. The authors developed and optimized a small-scale yet highly accurate guidance system that can be seamlessly integrated into an existing operating room (OR) setup due to its design. The aim of this clinical study is to outline the development of this miniature robotic guidance system and present the authors' clinical experience. METHODS: After extensive preclinical testing of the robotic stereotactic guidance system, adaptations were implemented for robot fixation, software usability, navigation integration, and end-effector application. Development of the robotic system was then advanced in a clinical series of 150 patients between 2013 and 2019, including 111 needle biopsies, 13 catheter placements, and 26 stereoelectroencephalography (SEEG) electrode placements. During the clinical trial, constant modifications were implemented to meet the setup requirements, technical specifications, and workflow for each indication. For each application, specific setup, workflow, and median procedural accuracy were evaluated. RESULTS: Application of the miniature robotic system was feasible in 149 of 150 cases. The setup in each procedure was successfully implemented without adding significant OR time. The workflow was seamlessly integrated into the preexisting procedure. In the course of the study, procedural accuracy was improved. For the biopsy procedure, the real target error (RTE) was reduced from a mean of 1.8 ± 1.03 mm to 1.6 ± 0.82 mm at entry (p = 0.05), and from 1.7 ± 1.12 mm to 1.6 ± 0.72 mm at target (p = 0.04). For the SEEG procedures, the RTE was reduced from a mean of 1.43 ± 0.78 mm in the first half of the procedures to 1.12 ± 0.52 mm (p = 0.002) at entry in the second half, and from 1.82 ± 1.13 mm to 1.57 ± 0.98 mm (p = 0.069) at target, respectively. No healing complications or infections were observed in any case. CONCLUSIONS: The miniature robotic guidance device was able to prove its versatility and seamless integration into preexisting workflow by successful application in 149 stereotactic procedures. According to these data, the robot could significantly improve accuracy without adding time expenditure.

Design of an Ultrasound-Navigated Prostate Cancer Biopsy System for Nationwide Implementation in Senegal.

This paper presents the design of NaviPBx, an ultrasound-navigated prostate cancer biopsy system. NaviPBx is designed to support an affordable and sustainable national healthcare program in Senegal. It uses spatiotemporal navigation and multiparametric transrectal ultrasound to guide biopsies. NaviPBx integrates concepts and methods that have been independently validated previously in clinical feasibility studies and deploys them together in a practical prostate cancer biopsy system. NaviPBx is based entirely on free open-source software and will be shared as a free open-source program with no restriction on its use. NaviPBx is set to be deployed and sustained nationwide through the Senegalese Military Health Service. This paper reports on the results of the design process of NaviPBx. Our approach concentrates on "frugal technology", intended to be affordable for low-middle income (LMIC) countries. Our project promises the wide-scale application of prostate biopsy and will foster time-efficient development and programmatic implementation of ultrasound-guided diagnostic and therapeutic interventions in Senegal and beyond.

Steerable needles for radio-frequency ablation in cirrhotic livers.

Accurate needle placement in deep-seated liver tumours can be difficult. In this work, we disclose two new manually controlled steerable needles for 17G radio-frequency ablation probe placement. The needles contain stylets with embedded compliant joints for active tip articulations, and concentric tubes for (curved-path) guidance. Needle steering was evaluated sequentially by intended users and in intended-use tissue types. Six interventional radiologists evaluated the needle in repeated ultrasound-guided steering tasks in liver-mimicking phantoms. Targets were located at a 100 mm depth and 20 mm lateral offset from the initial insertion line. The resulting mean absolute tip placement error was 1.0 ± 1.0 mm. Subsequently, steering-induced tissue damage was evaluated in fresh cirrhotic human liver explants. The surface area of puncture holes was estimated in scanned histology slides, using a connected-components analysis. The mean surface area was 0.26 ± 0.16 mm2 after steering with a median radius of curvature of 0.7 × 103 mm, versus 0.35 ± 0.15 mm2 after straight-path insertions with the steerable needle and 0.15 ± 0.09 mm2 after straight-path RFA probe insertions. The steering mechanisms proposed enable clinically relevant path corrections for 17G needles. Radiologists were quickly adept in curved-path RFA probe placement and the evaluation of histological tissue damage demonstrated a potentially safe use during liver interventions.