Background: This study investigated whether a machine-learning-based combination of radiomics and clinical parameters was superior to the use of clinical parameters alone in predicting therapy response after three months, and overall survival after six and twelve months, in stage-IV malignant melanoma patients undergoing immunotherapy with PD-1 checkpoint inhibitors and CTLA-4 checkpoint inhibitors. Methods: A random forest model using clinical parameters (demographic variables and tumor markers = baseline model) was compared to a random forest model using clinical parameters and radiomics (extended model) via repeated 5-fold cross-validation. For this purpose, the baseline computed tomographies of 262 stage-IV malignant melanoma patients treated at a tertiary referral center were identified in the Central Malignant Melanoma Registry, and all visible metastases were three-dimensionally segmented (n = 6404). Results: The extended model was not significantly superior compared to the baseline model for survival prediction after six and twelve months (AUC (95% CI): 0.664 (0.598, 0.729) vs. 0.620 (0.545, 0.692) and AUC (95% CI): 0.600 (0.526, 0.667) vs. 0.588 (0.481, 0.629), respectively). The extended model was not significantly superior compared to the baseline model for response prediction after three months (AUC (95% CI): 0.641 (0.581, 0.700) vs. 0.656 (0.587, 0.719)). Conclusions: The study indicated a potential, but non-significant, added value of radiomics for six-month and twelve-month survival prediction of stage-IV melanoma patients undergoing immunotherapy.

Purpose: AI-assisted techniques for lesion registration and segmentation have the potential to make CT-based tumor follow-up assessment faster and less reader-dependent. However, empirical evidence on the advantages of AI-assisted volumetric segmentation for lymph node and soft tissue metastases in follow-up CT scans is lacking. The aim of this study was to assess the efficiency, quality, and inter-reader variability of an AI-assisted workflow for volumetric segmentation of lymph node and soft tissue metastases in follow-up CT scans. Three hypotheses were tested: (H1) Assessment time for follow-up lesion segmentation is reduced using an AI-assisted workflow. (H2) The quality of the AI-assisted segmentation is non-inferior to the quality of fully manual segmentation. (H3) The inter-reader variability of the resulting segmentations is reduced with AI assistance. Materials and methods: The study retrospectively analyzed 126 lymph nodes and 135 soft tissue metastases from 55 patients with stage IV melanoma. Three radiologists from two institutions performed both AI-assisted and manual segmentation, and the results were statistically analyzed and compared to a manual segmentation reference standard. Results: AI-assisted segmentation reduced user interaction time significantly by 33% (222 s vs. 336 s), achieved similar Dice scores (0.80–0.84 vs. 0.81–0.82) and decreased inter-reader variability (median Dice 0.85–1.0 vs. 0.80–0.82; ICC 0.84 vs. 0.80), compared to manual segmentation. Conclusion: The findings of this study support the use of AI-assisted registration and volumetric segmentation for lymph node and soft tissue metastases in follow-up CT scans. The AI-assisted workflow achieved significant time savings, similar segmentation quality, and reduced inter-reader variability compared to manual segmentation.

Objectives: To evaluate the performance of a custom-made convolutional neural network (CNN) algorithm for fully automated lesion tracking and segmentation, as well as RECIST 1.1 evaluation, in longitudinal computed tomography (CT) studies compared to a manual Response Evaluation Criteria in Solid Tumors (RECIST 1.1) evaluation performed by three radiologists. Methods: Baseline and follow-up CTs of patients with stage IV melanoma (n = 58) was investigated in a retrospective reading study. Three radiologists performed manual measurements of metastatic lesions. Fully automated segmentations were generated, and diameters and volumes were computed from the segmentation results, with subsequent RECIST 1.1 evaluation. We measured (1) the intra- and inter-reader variability in the manual diameter measurements, (2) the agreement between manual and automated diameter measurements, as well as the resulting RECIST 1.1 categories, and (3) the agreement between the RECIST 1.1 categories derived from automated diameter measurement compared to automated volume measurements. Results: In total, 114 target lesions were measured at baseline and follow-up. The intraclass correlation coefficients (ICCs) for the intra- and inter-reader reliability of the diameter measurements were excellent, being >0.90 for all readers. There was moderate to almost perfect agreement when comparing the timepoint response category derived from the mean manual diameter measurements from all three readers with those derived from automated diameter measurements (Cohen’s k 0.67–0.76). The agreement between the manual and automated volumetric timepoint responses was substantial (Fleiss’ k 0.66–0.68) and that between the automated diameter and volume timepoint responses was substantial to almost perfect (Cohen’s k 0.81). Conclusions: The automated diameter measurement of preselected target lesions in follow-up CT is reliable and can potentially help to accelerate RECIST evaluation.

Objectives: To evaluate the predictive performance of the modified hepatoma arterial embolisation prognostic II (mHAP-II) score in a real-life western hepatocellular carcinoma (HCC) cohort treated with drug-eluting bead-TACE and compare the mHAP-II with other scores in this cohort.Methods: One hundred seventy-nine HCC patients (mean age 77 (± 9) years, 87% male) with one or more drug-eluting bead (DEB)-TACE sessions using 100–300 μm microspheres were retrospectively analysed. Performance analysis of the mHAP-II score was based on Mann-WhitneyUtests, the Kaplan-Meier method, log-rank tests, receiver operating characteristics, Akaike’s information criterion and Cox regression models.Results: In this population, HCC risk factors were mainly alcohol abuse (31%) and hepatitis C (28%). The median survival of the entire cohort was 29.4 months. mHAP-II classification of the cohort was mHAP-II B (30%), C (41%) and D (23%) respectively. Survival of all subgroups differed significantly from each other (eachp < 0.05). Area under the curve for receiver operating characteristic was 0.60 and Akaike’s information criterion was 21.8 (p = 0.03), indicating a superior performance of mHAP-II score compared with HAP score and BCLC. Tumour number ≥ two (HR 1.54), alpha-fetoprotein > 400 μg/l (HR 1.14), serum albumin < 3.6 g/dl (HR 1.63) and total bilirubin > 0.9 mg/dl (HR 1.58) contributed significantly in Cox proportional hazards regression (eachp < 0.05).Conclusion: The mHAP-II score can predict survival outcomes of western HCC patients undergoing DEB-TACE and further subdivide this heterogeneous group; however, certain limitations concerning the predictive power of mHAP-II score must be taken into account.Key Points: • This retrospective study evaluated the predictive performance of the modified hepatoma arterial embolisation prognostic II (mHAP-II) score in a real-life western HCC cohort treated with drug-eluting bead-TACE.• Survival of all mHAP-II subgroups differed significantly, area under the curve for mHAP-II was 0.60 and Akaike’s information criterion was 21.8.• The mHAP-II score can predict survival outcomes of western HCC patients undergoing DEB-TACE and further subdivide this heterogeneous group. However, because the study is underpowered, true survival prediction may be more difficult to infer.

(1) Background: To evaluate the diagnostic performance of a simulated ultra-low-dose (ULD), high-pitch computed tomography pulmonary angiography (CTPA) protocol with low tube current (mAs) and reduced scan range for detection of pulmonary embolisms (PE). (2) Methods: We retrospectively included 130 consecutive patients (64 ± 16 years, 69 female) who underwent clinically indicated high-pitch CTPA examination for suspected acute PE on a 3rd generation dual-source CT scanner (SOMATOM FORCE, Siemens Healthineers, Forchheim, Germany). ULD datasets with a realistic simulation of 25% mAs, reduced scan range (aortic arch—basal pericardium), and Advanced Modeled Iterative Reconstruction (ADMIRE®, Siemens Healthineers, Forchheim, Germany) strength 5 were created. The effective radiation dose (ED) of both datasets (standard and ULD) was estimated using a dedicated dosimetry software solution. Subjective image quality and diagnostic confidence were evaluated independently by three reviewers using a 5-point Likert scale. Objective image quality was compared using noise measurements. For assessment of diagnostic accuracy, patients and pulmonary vessels were reviewed binarily for affection by PE, using standard CTPA protocol datasets as the reference standard. Percentual affection of pulmonary vessels by PE was computed for disease severity (modified Qanadli score). (3) Results: Mean ED in ULD protocol was 0.7 ± 0.3 mSv (16% of standard protocol: 4.3 ± 1.7 mSv, p < 0.001, r > 0.5). Comparing ULD to standard protocol, subjective image quality and diagnostic confidence were comparably good (p = 0.486, r > 0.5) and image noise was significantly lower in ULD (p < 0.001, r > 0.5). A total of 42 patients (32.2%) were affected by PE. ULD protocol had a segment-based false-negative rate of only 0.1%. Sensitivity for detection of any PE was 98.9% (95% CI, 97.2–99.7%), specificity was 100% (95% CI, 99.8–100%), and overall accuracy was 99.9% (95% CI, 98.6–100%). Diagnoses correlated strongly between ULD and standard protocol (Chi-square (1) = 42, p < 0.001) with a decrease in disease severity of only 0.48% (T = 1.667, p = 0.103). (4) Conclusions: Compared to a standard CTPA protocol, the proposed ULD protocol proved reliable in detecting and ruling out acute PE with good levels of image quality and diagnostic confidence, as well as significantly lower image noise, at 0.7 ± 0.3 mSv (84% dose reduction).

To evaluate the effect of radiation dose reduction on image quality and diagnostic confidence in contrast-enhanced whole-body computed tomography (WBCT) staging. We randomly selected March 2016 for retrospective inclusion of 18 consecutive patients (14 female, 60 ± 15 years) with clinically indicated WBCT staging on the same 3rd generation dual-source CT. Using low-dose simulations, we created data sets with 100, 80, 60, 40, and 20% of the original radiation dose. Each set was reconstructed using filtered back projection (FBP) and Advanced Modeled Iterative Reconstruction (ADMIRE^®, Siemens Healthineers, Forchheim, Germany) strength 1–5, resulting in 540 datasets total. ADMIRE 2 was the reference standard for intraindividual comparison. The effective radiation dose was calculated using commercially available software. For comparison of objective image quality, noise assessments of subcutaneous adipose tissue regions were performed automatically using the software. Three radiologists blinded to the study evaluated image quality and diagnostic confidence independently on an equidistant 5-point Likert scale (1 = poor to 5 = excellent). At 100%, the effective radiation dose in our population was 13.3 ± 9.1 mSv. At 20% radiation dose, it was possible to obtain comparably low noise levels when using ADMIRE 5 (p = 1.000, r = 0.29). We identified ADMIRE 3 at 40% radiation dose (5.3 ± 3.6 mSv) as the lowest achievable radiation dose with image quality and diagnostic confidence equal to our reference standard (p = 1.000, r > 0.4). The inter-rater agreement for this result was almost perfect (ICC ≥ 0.958, 95% CI 0.909–0.983). On a 3rd generation scanner, it is feasible to maintain good subjective image quality, diagnostic confidence, and image noise in single-energy WBCT staging at dose levels as low as 40% of the original dose (5.3 ± 3.6 mSv), when using ADMIRE 3.