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Background: This observational study aims to establish the feasibility of using x-ray images of radio-opaque chemoembolisation deposits in patients as a method for real-time image-guided radiation therapy of hepatocellular carcinoma. Methods: This study will recruit 50 hepatocellular carcinoma patients who have had or will have stereotactic ablative radiation therapy and have had transarterial chemoembolisation with a radio-opaque agent. X-ray and computed tomography images of the patients will be analysed retrospectively. Additionally, a deep learning method for real-time motion tracking will be developed. We hypothesise that: (i) deep learning software can be developed that will successfully track the contrast agent mass on two thirds of cone beam computed tomography (CBCT) projection and intra-treatment images (ii), the mean and standard deviation (mm) difference in the location of the mass between ground truth and deep learning detection are ≤ 2 mm and ≤ 3 mm respectively and (iii) statistical modelling of study data will predict tracking success in 85% of trial participants. Discussion: Developing a real-time tracking method will enable increased targeting accuracy, without the need for additional invasive procedures to implant fiducial markers. Trial registration: Registered to ClinicalTrials.gov (NCT05169177) 12th October 2021. [ABSTRACT FROM AUTHOR]

Abstract Background This observational study aims to establish the feasibility of using x-ray images of radio-opaque chemoembolisation deposits in patients as a method for real-time image-guided radiation therapy of hepatocellular carcinoma. Methods This study will recruit 50 hepatocellular carcinoma patients who have had or will have stereotactic ablative radiation therapy and have had transarterial chemoembolisation with a radio-opaque agent. X-ray and computed tomography images of the patients will be analysed retrospectively. Additionally, a deep learning method for real-time motion tracking will be developed. We hypothesise that: (i) deep learning software can be developed that will successfully track the contrast agent mass on two thirds of cone beam computed tomography (CBCT) projection and intra-treatment images (ii), the mean and standard deviation (mm) difference in the location of the mass between ground truth and deep learning detection are ≤ 2 mm and ≤ 3 mm respectively and (iii) statistical modelling of study data will predict tracking success in 85% of trial participants. Discussion Developing a real-time tracking method will enable increased targeting accuracy, without the need for additional invasive procedures to implant fiducial markers. Trial registration Registered to ClinicalTrials.gov (NCT05169177) 12th October 2021.

This study quantified the performance of Intra-fraction Motion Review (IMR) during prostate Stereotactic Body Radiotherapy (SBRT) treatments. IMR was evaluated using prostate motion data from patients treated in an SBRT clinical trial (PROMETHEUS, NCT00587990).IMR measured prostate displacements were compared to those of two 3D motion management methods: Kilovoltage Intra-fraction Motion management (KIM) and MV/kV triangulation. A planning study assessing the impact of a defined prostate motion (2–5 mm) on the PTV coverage with and without IMR was performed. A clinically relevant IMR search region for prostate cancer SBRT treatments was determined using a customised anthropomorphic pelvis phantom with implanted gold seeds and a motion platform. IMR showed submillimeter agreement with corresponding 2D projections from both KIM and MV/kV triangulation. However, IMR detected actual displacements consistently in considerably fewer frames than KIM (3D), with the actual numbers depending on the settings. The Default Search Region (DSR) method employing a circular search region proved superior to user-contoured structures in detecting clinically relevant prostate motion. Reducing the DSR search region radius can reduce the impact of the 2D nature of IMR and improve the detectability of actual motion (by 10% per 0.5 mm reduction) but must be balanced against increased beam interruptions from minor, clinically irrelevant motion. The use of IMR for SBRT prostate treatments has the potential to improve target dose coverage (minimum dose to 98% of the PTV, D98%) by > 20% compared to treatment without IMR. Calculated D98% of IMR monitored treatments with motion was within 1.5% of plans without motion. [ABSTRACT FROM AUTHOR]

Abstract Background Stereotactic Ablative Body Radiotherapy (SABR) is a non-invasive treatment which allows delivery of an ablative radiation dose with high accuracy and precision. SABR is an established treatment for both primary and secondary liver malignancies, and technological advances have improved its efficacy and safety. Respiratory motion management to reduce tumour motion and image guidance to achieve targeting accuracy are crucial elements of liver SABR. This phase II multi-institutional TROG 17.03 study, Liver Ablative Radiotherapy using Kilovoltage intrafraction monitoring (LARK), aims to investigate and assess the dosimetric impact of the KIM real-time image guidance technology. KIM utilises standard linear accelerator equipment and therefore has the potential to be a widely available real-time image guidance technology for liver SABR. Methods Forty-six patients with either hepatocellular carcinoma or oligometastatic disease to the liver suitable for and treated with SABR using Kilovoltage Intrafraction Monitoring (KIM) guidance will be included in the study. The dosimetric impact will be assessed by quantifying accumulated patient dose distribution with or without the KIM intervention. The patient treatment outcomes of local control, toxicity and quality of life will be measured. Discussion Liver SABR is a highly effective treatment, but precise dose delivery is challenging due to organ motion. Currently, there is a lack of widely available options for performing real-time tumour localisation to assist with accurate delivery of liver SABR. This study will provide an assessment of the impact of KIM as a potential solution for real-time image guidance in liver SABR. Trial registration This trial was registered on December 7th 2016 on ClinicalTrials.gov under the trial-ID NCT02984566 .

Background: Stereotactic Ablative Body Radiotherapy (SABR) is a non-invasive treatment which allows delivery of an ablative radiation dose with high accuracy and precision. SABR is an established treatment for both primary and secondary liver malignancies, and technological advances have improved its efficacy and safety. Respiratory motion management to reduce tumour motion and image guidance to achieve targeting accuracy are crucial elements of liver SABR. This phase II multi-institutional TROG 17.03 study, Liver Ablative Radiotherapy using Kilovoltage intrafraction monitoring (LARK), aims to investigate and assess the dosimetric impact of the KIM real-time image guidance technology. KIM utilises standard linear accelerator equipment and therefore has the potential to be a widely available real-time image guidance technology for liver SABR.Methods: Forty-six patients with either hepatocellular carcinoma or oligometastatic disease to the liver suitable for and treated with SABR using Kilovoltage Intrafraction Monitoring (KIM) guidance will be included in the study. The dosimetric impact will be assessed by quantifying accumulated patient dose distribution with or without the KIM intervention. The patient treatment outcomes of local control, toxicity and quality of life will be measured.Discussion: Liver SABR is a highly effective treatment, but precise dose delivery is challenging due to organ motion. Currently, there is a lack of widely available options for performing real-time tumour localisation to assist with accurate delivery of liver SABR. This study will provide an assessment of the impact of KIM as a potential solution for real-time image guidance in liver SABR.Trial Registration: This trial was registered on December 7th 2016 on ClinicalTrials.gov under the trial-ID NCT02984566 . [ABSTRACT FROM AUTHOR]

• Tumor motion during liver SBRT can compromise the tumor dose. • KIM-guided MLC tracking can restore the tumor dose coverage. • Tumor motion perpendicular to the MLC leaves can create dose hotspots in the tumor. To investigate the potential benefit of multileaf collimator (MLC) tracking guided by kilovoltage intrafraction monitoring (KIM) during stereotactic body radiotherapy (SBRT) in the liver, and to understand trends of target overdose with MLC tracking. Six liver SBRT patients with 2–3 implanted gold markers received SBRT delivered with volumetric modulated arc therapy (VMAT) in three fractions using daily cone-beam CT setup. The CTV-to-PTV margins were 5 mm in the axial plane and 10 mm in the cranio-caudal directions, and the plans were designed to give minimum target doses of 95% (CTV) and 67% (PTV). The three-dimensional marker trajectory estimated by post-treatment analysis of kV fluoroscopy images acquired throughout treatment delivery was assumed to represent the tumor motion. MLC tracking guided by real-time KIM was simulated. The reduction in CTV D95 (minimum dose to 95% of the clinical target volume) relative to the planned D95 (ΔD95) was compared between actual non-tracking and simulated MLC tracking treatments. MLC tracking maintained a high CTV dose coverage for all 18 fractions with ΔD95 (mean: 0.2 percentage points (pp), range: −1.7 to 1.9 pp) being significantly lower than for the actual non-tracking treatments (mean: 6.3 pp range: 0.6–16.0 pp) (p = 0.002). MLC tracking of large target motion perpendicular to the MLC leaves created dose artifacts with regions of overdose in the CTV. As a result, the mean dose in spherical volumes centered in the middle of the CTV was on average 2.4 pp (5 mm radius sphere) and 1.3 pp (15 mm radius sphere) higher than planned (p = 0.002). Intrafraction tumor motion can deteriorate the CTV dose of liver SBRT. The planned CTV dose coverage may be restored with KIM-guided MLC tracking. However, MLC tracking may have a tendency to create hotspots in the CTV. [ABSTRACT FROM AUTHOR]

Purpose: Kilovoltage intrafraction monitoring (KIM) allows for real‐time image guidance for tracking tumor motion in six‐degrees‐of‐freedom (6DoF) on a standard linear accelerator. This study assessed the geometric accuracy and precision of KIM used to guide patient treatments in the TROG 15.01 multi‐institutional Stereotactic Prostate Ablative Radiotherapy with KIM trial and investigated factors affecting accuracy and precision. Methods: Fractions from 44 patients with prostate cancer treated using KIM‐guided SBRT were analyzed across four institutions, on two different linear accelerator models and two different beam models (6 MV and 10 MV FFF). The geometric accuracy and precision of KIM was assessed from over 33 000 images (translation) and over 9000 images (rotation) by comparing the real‐time measured motion to retrospective kV/MV triangulation. Factors potentially affecting accuracy, including contrast‐to‐noise ratio (CNR) of kV images and incorrect marker segmentation, were also investigated. Results: The geometric accuracy and precision did not depend on treatment institution, beam model or motion magnitude, but was correlated with gantry angle. The centroid geometric accuracy and precision of the KIM system for SABR prostate treatments was 0.0 ± 0.5, 0.0 ± 0.4 and 0.1 ± 0.3 mm for translation, and −0.1 ± 0.6°, −0.1 ± 1.4° and −0.1 ± 1.0° for rotation in the AP, LR and SI directions respectively. Centroid geometric error exceeded 2 mm for 0.05% of this dataset. No significant relationship was found between large geometric error and CNR or marker segmentation correlation. Conclusions: This study demonstrated the ability of KIM to locate the prostate with accuracy below other uncertainties in radiotherapy treatments, and the feasibility for KIM to be implemented across multiple institutions. [ABSTRACT FROM AUTHOR]

Purpose The focus of this work was to improve the available kV image quality for continuous intrafraction monitoring of the prostate during volumetric modulated arc therapy. This is investigated using a novel blade collimation system enabling tube current modulated (TCM) volume-of-interest (VOI) imaging of prostate fiducial markers during radiotherapy, and Monte Carlo simulation of MV scatter. Materials and methods A four-blade dynamic kV collimator was used to track a VOI containing gold fiducial markers embedded in a dynamic pelvis phantom during gantry rotation. For each fiducial, a VOI margin around each marker was set to be 2σ of the population covariance matrix characterizing prostate motion. This was used to conform to a single or several fiducials and compared to a static field. DRRs were used to calculate the kV attenuation for each VOI as a function of angle and used to optimize x-ray tube current during acquisition. Image quality was assessed with regard to contrast-to-noise ratio (CNR), fiducial detectability, and imaging dose. Monte Carlo simulations in EGSnrc were used to calculate the imaging dose to the phantom and MV scatter fluence to the imaging panel. Results Fiducials can be accurately located using a VOI containing a single or several fiducials using a relatively high constant kV output. However, when using a 6 × 6 cm2 field the dose can be upwards of 1.5 Gy in bone for constant kV output and 3.1 Gy when applying TCM at 1 Hz imaging over the course of 40 fractions. This can be mitigated through tailoring the imaging field to a single or several fiducials, in which the integral dose is reduced by a factor of 15.6 and 3.7, respectively. For a constant MV treatment field size, the scattered fluence reaching the kV panel varies by less than a factor of two for a completely rotation of the gantry. However, the MV scatter spectrum overlaps with the detector response for a deleterious effect, with a peak MV scatter energy of approximately 100 keV. TCM can be used to overcome the variability in image quality throughout the rotation and therefore improve fiducial CNR and detectability during periods of high kV attenuation. Conclusions The combination of VOI and TCM introduces an advantageous approach in intrafraction monitoring of the prostate during radiotherapy by both reducing and localizing the imaging dose, while improving image quality and fiducial detectability during periods of high kV attenuation. In addition, the influence of MV scatter has been shown to be most important in low attenuation regions, with a variation by a factor of two. [ABSTRACT FROM AUTHOR]

Background: This paper describes the multi-institutional prospective phase II clinical trial, SPARK: Stereotactic Prostate Adaptive Radiotherapy utilizing Kilovoltage Intrafraction Monitoring (KIM). KIM is a real-time image guided radiotherapy technology being developed and clinically pioneered for prostate cancer treatment in Australia. It has potential for widespread use for target radiotherapy treatment of cancers of the pelvis, thorax and abdomen.Methods: In the SPARK trial we will measure the cancer targeting accuracy and patient outcomes for 48 prostate cancer patients who will be treated in five treatment sessions as opposed to the conventional 40 sessions. The reduced number of treatment sessions is enabled by the KIM's increased cancer targeting accuracy.Discussion: Real-time imaging in radiotherapy has the potential to decrease the time taken during cancer treatment and reduce the imaging dose required. With the imaging being acquired during the treatment, and the analysis being automated, there is potential for improved throughput. The SPARK trial will be conducted under the auspices of the Trans-Tasman Radiation Oncology Group (TROG).Trial Registration: This trial was registered on ClinicalTrials.gov on 09 March 2015. The identifier is: NCT02397317. [ABSTRACT FROM AUTHOR]

Purpose: Kilovoltage intrafraction monitoring (KIM) is a real-time image guidance method that uses widely available radiotherapy technology, i.e., a gantry-mounted x-ray imager. The authors report on the geometric and dosimetric results of the first patient treatment using KIM which occurred on September 16, 2014. Methods: KIM uses current and prior 2D x-ray images to estimate the 3D target position during cancer radiotherapy treatment delivery. KIM software was written to process kilovoltage (kV) images streamed from a standard C-arm linear accelerator with a gantry-mounted kV x-ray imaging system. A 120° pretreatment kV imaging arc was acquired to build the patient-specific 2D to 3D motion correlation. The kV imager was activated during the megavoltage (MV) treatment, a dual arc VMAT prostate treatment, to estimate the 3D prostate position in real-time. All necessary ethics, legal, and regulatory requirements were met for this clinical study. The quality assurance processes were completed and peer reviewed. Results: During treatment, a prostate position offset of nearly 3 mm in the posterior direction was observed with KIM. This position offset did not trigger a gating event. After the treatment, the prostate motion was independently measured using kV/MV triangulation, resulting in a mean difference of less than 0.6 mm and standard deviation of less than 0.6 mm in each direction. The accuracy of the marker segmentation was visually assessed during and after treatment and found to be performing well. During treatment, there were no interruptions due to performance of the KIM software. Conclusions: For the first time, KIM has been used for real-time image guidance during cancer radiotherapy. The measured accuracy and precision were both submillimeter for the first treatment fraction. This clinical translational research milestone paves the way for the broad implementation of real-time image guidance to facilitate the detection and correction of geometric and dosimetric errors, and resultant improved clinical outcomes, in cancer radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Kilovoltage intrafraction monitoring (KIM) is a real-time 3D tumor monitoring system for cancer radiotherapy. KIM uses the commonly available gantry-mounted x-ray imager as input, making this method potentially more widely available than dedicated real-time 3D tumor monitoring systems. K IM is being piloted in a clinical trial for prostate cancer patients treated with VMAT (NCT01742403). The purpose of this work was to develop clinical process and quality assurance (QA) practices for the clinical implementation of KIM. Methods: Informed by and adapting existing guideline documents from other real-time monitoring systems, KIM-specific QA practices were developed. The following five KIM-specific QA tests were included: (1) static localization accuracy, (2) dynamic localization accuracy, (3) treatment interruption accuracy, (4) latency measurement, and (5) clinical conditions accuracy. Tests (1)-(4) were performed using K IM to measure static and representative patient-derived prostate motion trajectories using a 3D programmable motion stage supporting an anthropomorphic phantom with implanted gold markers to represent the clinical treatment scenario. The threshold for system tolerable latency is <1 s. The tolerances for all other tests are that both the mean and standard deviation of the difference between the programmed trajectory and the measured data are <1 mm. The (5) clinical conditions accuracy test compared the K IM measured positions with those measured by kV/megavoltage (MV) triangulation from five treatment fractions acquired in a previous pilot study. Results: For the (1) static localization, (2) dynamic localization, and (3) treatment interruption accuracy tests, the mean and standard deviation of the difference are <1.0 mm. (4) The measured latency is 350 ms. (5) For the tests with previously acquired patient data, the mean and standard deviation of the difference between KIM and kV/MV triangulation are <1.0 mm. Conclusions: Clinical process and QA practices for the safe clinical implementation of KIM, a novel real-time monitoring system using commonly available equipment, have been developed and implemented for prostate cancer VMAT. [ABSTRACT FROM AUTHOR]