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Simple Summary: While the initial favorable efficacy and safety profile for a novel diffusing alpha-emitter radiation therapy (Alpha DaRT) have been previously demonstrated, the longer-term safety and durability of the treatment are unknown. In this pooled analysis of 81 treated head and neck or skin tumors from four clinical trials with a median follow-up of 14 months, a complete response was observed in 89% of treated lesions, two-year local recurrence-free survival was 77%, and there were no grade 2 or higher late toxicities observed. These results suggest that Alpha DaRT is a safe and effective treatment for skin and head and neck tumors. The initial favorable efficacy and safety profile for Alpha DaRT have been demonstrated (NCT04377360); however, the longer-term safety and durability of the treatment are unknown. This pooled analysis of four prospective trials evaluated the long-term safety and efficacy of Alpha DaRT for the treatment of head and neck or skin tumors. A total of 81 lesions in 71 patients were treated across six international institutions, with a median follow-up of 14.1 months (range: 2–51 months). Alpha DaRT sources were delivered via a percutaneous interstitial technique and placed to irradiate the tumor volume with the margin. The sources were removed two to three weeks following implantation. A complete response was observed in 89% of treated lesions (n = 72) and a partial response in 10% (n = 8). The two-year actuarial local recurrence-free survival was 77% [95% CI 63–87]. Variables, including recurrent versus non-recurrent lesions, baseline tumor size, or histology, did not impact long-term outcomes. Twenty-seven percent of patients developed related acute grade 2 or higher toxicities, which resolved with conservative measures. No grade 2 or higher late toxicities were observed. These data support the favorable safety profile of Alpha DaRT, which is currently being explored in a pivotal US trial. [ABSTRACT FROM AUTHOR]

Featured Application: The results of this work may promote the clinical application of the DirectDensity® CT reconstruction algorithm as a basis for radiation therapy dose calculations in different clinical situations (e.g., metal implants artifacts), allowing for a more personalized workflow while ensuring simplicity and solidity. The DirectDensity® CT reconstruction algorithm provides a reconstruction approach independent of the tube voltage, directly reconstructing the CT projection data into CT numbers related to the electron densities of the materials. This work examines the efficacy of DirectDensity® in the treatment planning process with both tissues and metallic materials. CT scans of a Cheese phantom were acquired at 80, 100, 120 and 140 kVp and reconstructed with different algorithms. Calibration curves were built for each kVp and reconstruction technique. To evaluate the flexibility of the DirectDensity® in dose calculations, a prostate cancer treatment plan was simulated on phantom images with and without metal inserts. Moreover, the robustness of the algorithm was tested by simulating a possible error in the selection of the calibration curve. As expected, the calibration curves related to DirectDensity® showed a tube voltage dependence only for densities above 1.82 g/cm3. The maximum percentage differences in dose distributions comparations never exceeded the 3% of tolerance and the 3D gamma analysis always returned indices greater than 90%. The results suggest that the DD reconstruction algorithm can be employed in most clinical cases and allows for a personalized radiotherapy cancer treatment workflow, maintaining its robustness and simplicity. [ABSTRACT FROM AUTHOR]

Simple Summary: Radiomics analysis is used on magnetic resonance imaging – apparent diffusion coefficient (MRI-ADC) maps and [68Ga]Ga-PSMA-11 PET uptake maps to assess unique tumor traits not visible to the naked eye and predict histology-proven ISUP grades in a cohort of 28 patients. Our study's main goal is to report imaging features that can distinguish patients with low ISUP grades from those with higher grades (ISUP one+) by employing logistic regression statistical models based on MRI-ADC and 68Ga-PSMA data, as well as assess the features' stability under small contouring variations. Our findings reveal that MRI-ADC and [68Ga]Ga-PSMA-11 PET imaging features-based models are equivalent and complementary for predicting low ISUP grade patients. These models can be employed in broader studies to confirm their ISUP grade prediction ability and eventually impact clinical workflow by reducing overdiagnosis of indolent, early-stage PCa. Prostate cancer (PCa) risk categorization based on clinical/PSA testing results in a substantial number of men being overdiagnosed with indolent, early-stage PCa. Clinically non-significant PCa is characterized as the presence of ISUP grade one, where PCa is found in no more than two prostate biopsy cores.MRI-ADC and [68Ga]Ga-PSMA-11 PET have been proposed as tools to predict ISUP grade one patients and consequently reduce overdiagnosis. In this study, Radiomics analysis is applied to MRI-ADC and [68Ga]Ga-PSMA-11 PET maps to quantify tumor characteristics and predict histology-proven ISUP grades. ICC was applied with a threshold of 0.6 to assess the features' stability with variations in contouring. Logistic regression predictive models based on imaging features were trained on 31 lesions to differentiate ISUP grade one patients from ISUP two+ patients. The best model based on [68Ga]Ga-PSMA-11 PET returned a prediction efficiency of 95% in the training phase and 100% in the test phase whereas the best model based on MRI-ADC had an efficiency of 100% in both phases. Employing both imaging modalities, prediction efficiency was 100% in the training phase and 93% in the test phase. Although our patient cohort was small, it was possible to assess that both imaging modalities add information to the prediction models and show promising results for further investigations. [ABSTRACT FROM AUTHOR]

Background: Digital breast tomosynthesis (DBT) systems employ a sophisticated set of acquisition parameters to generate an image set, and the DBT acquisition angle is considered to be one of the most important parameters. The aim of this study was to use texture analysis to assess how the DBT acquisition angle might influence DBT images of breast parenchyma. Methods: Thirty-four patients were selected from a clinical study conducted at IRST Institute. Each patient underwent a dual DBT scan performed with Fujifilm Amulet Innovality (Fujifilm Corp, Tokyo, Japan) in standard (ST, angular range = 15°) and high-resolution (HR, angular range = 40°) modalities. Texture analysis was applied on the paired dataset using histogram-based features and gray level co-occurrence matrix (GLCM) features. Wilcoxon-signed rank and Pearson-rank tests were used to assess the statistical differences and correlations between extracted features. Results: The DBT acquisition angle did not affect histogram-based features, whereas there was a significant difference in five GLCM features (p < 0.05) between DBT images generated with 15° and 40° acquisition angles. Correlation analysis showed that two GLCM features were not correlated at a p < 0.05 significance level. Conclusions: DBT acquisition angle affects the textures extracted from DBT images and this dependence should be considered when establishing baselines for classifiers of malignant tissue. Furthermore, texture analysis could be proposed as a quantitative method for comparing and scoring the contrast of DBT images. [ABSTRACT FROM AUTHOR]

Simple Summary: The Diffusing Alpha-emitters Radiation Therapy (DaRT) is a novel brachytherapy technique employing 224-radium enriched seeds releasing short-lived alpha-emitting atoms into the tumour. DaRT overcomes the main obstacle in employing alpha radiation for cancer treatments in liquid and solid media caused by their short range. The aim of the study is to improve the DaRT technique with an external radio-opaque template that can help clinicians predict the correct number of sources to achieve tumour coverage. Furthermore, the template is used to aid clinicians in visualizing lesions and their eventual subcutaneous extension. Finally, it is also utilized on treatment day to ensure that the sources are properly inserted into the tumour. The purpose of this study is to discuss how to use an external radio-opaque template in the Diffusing Alpha-emitters Radiation Therapy (DaRT) technique's pre-planning and treatment stages. This device would help to determine the proper number of sources for tumour coverage, accounting for subcutaneous invasion and augmenting DaRT safety. The procedure will be carried out in a first phase on a phantom and then applied to a clinical case. A typical DaRT procedure workflow comprises steps like tumour measurements and delineation, source number assessment, and therapy administration. As a first step, an adhesive fiberglass mesh (spaced by 2 mm) tape was applied on the skin of the patient and employed as frame of reference. A physician contoured the lesion and marked the entrance points for the needles with a radio opaque ink marker. According to the radio opaque marks and metabolic uptake the clinical target volume was defined, and with a commercial brachytherapy treatment planning system (TPS) it was possible to simulate and adjust the spatial seeds distribution. After the implant procedure a CT was again performed to check the agreement between simulations and seeds positions. With the procedure described above it was possible to simulate a DaRT procedure on a phantom in order to train physicians and subsequently apply the novel approach on patients, outlining the major issues involved in the technique. The present work innovates and supports DaRT technique for the treatment of cutaneous cancers, improving its efficacy and safety. [ABSTRACT FROM AUTHOR]