Radiology
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Randomized Controlled Trial
Added Value of Deep Learning-based Detection System for Multiple Major Findings on Chest Radiographs: A Randomized Crossover Study.
Background Previous studies assessing the effects of computer-aided detection on observer performance in the reading of chest radiographs used a sequential reading design that may have biased the results because of reading order or recall bias. Purpose To compare observer performance in detecting and localizing major abnormal findings including nodules, consolidation, interstitial opacity, pleural effusion, and pneumothorax on chest radiographs without versus with deep learning-based detection (DLD) system assistance in a randomized crossover design. Materials and Methods This study included retrospectively collected normal and abnormal chest radiographs between January 2016 and December 2017 (https://cris.nih.go.kr/; registration no. ⋯ Use of the DLD system improved the observers' JAFROC FOM (from 0.90 to 0.95, P = .002), AUC (from 0.93 to 0.98, P = .002), per-lesion sensitivity (from 83% [822 of 990 lesions] to 89.1% [882 of 990 lesions], P = .009), per-image sensitivity (from 80% [548 of 684 radiographs] to 89% [608 of 684 radiographs], P = .009), and specificity (from 89.3% [611 of 684 radiographs] to 96.6% [661 of 684 radiographs], P = .01) and reduced the reading time (from 10-65 seconds to 6-27 seconds, P < .001). The DLD system alone outperformed the pooled observers (JAFROC FOM: 0.96 vs 0.90, respectively, P = .007; AUC: 0.98 vs 0.93, P = .003). Conclusion Observers including thoracic radiologists showed improved performance in the detection and localization of major abnormal findings on chest radiographs and reduced reading time with use of a deep learning-based detection system. © RSNA, 2021 Online supplemental material is available for this article.
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Randomized Controlled Trial Comparative Study
Comparing Screening Outcomes for Digital Breast Tomosynthesis and Digital Mammography by Automated Breast Density in a Randomized Controlled Trial: Results from the To-Be Trial.
Background Digital breast tomosynthesis (DBT) is considered superior to digital mammography (DM) for women with dense breasts. Purpose To identify differences in screening outcomes, including rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM. Materials and Methods This randomized controlled trial comparing DBT+SM and DM was performed in Bergen as part of BreastScreen Norway, 2016-2017. ⋯ Conclusion Screening with digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM) yielded lower recall rates for women with Volpara Density Grade (VDG) 1 and VDG 2. Adjusted relative risk of recall and screen-detected breast cancer increased with denser breasts for DBT+SM but not for DM. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Sechopoulos and Athanasiou in this issue.
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Randomized Controlled Trial Multicenter Study
Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial.
Purpose To determine if the change in tumor apparent diffusion coefficient (ADC) at diffusion-weighted (DW) MRI is predictive of pathologic complete response (pCR) to neoadjuvant chemotherapy for breast cancer. Materials and Methods In this prospective multicenter study, 272 consecutive women with breast cancer were enrolled at 10 institutions (from August 2012 to January 2015) and were randomized to treatment with 12 weekly doses of paclitaxel (with or without an experimental agent), followed by 12 weeks of treatment with four cycles of anthracycline. Each woman underwent breast DW MRI before treatment, at early treatment (3 weeks), at midtreatment (12 weeks), and after treatment. ⋯ Across the four disease subtypes, midtreatment ΔADC was predictive only for HR+/HER2- tumors (AUC = 0.76; 95% CI: 0.62, 0.89; P < .001). In a test subset, a model combining tumor subtype and midtreatment ΔADC improved predictive performance (AUC = 0.72; 95% CI: 0.61, 0.83) over ΔADC alone (AUC = 0.57; 95% CI: 0.44, 0.70; P = .032.). Conclusion After 12 weeks of therapy, change in breast tumor apparent diffusion coefficient at MRI predicts complete pathologic response to neoadjuvant chemotherapy. © RSNA, 2018 Online supplemental material is available for this article.
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Randomized Controlled Trial
Superior Hypogastric Nerve Block as Post-Uterine Artery Embolization Analgesia: A Randomized and Double-Blind Clinical Trial.
Purpose To evaluate the effectiveness of superior hypogastric nerve block (SHNB) in reducing narcotic use after uterine artery embolization (UAE). Materials and Methods This study was a prospective, randomized, double-blind, parallel clinical trial in patients referred to a tertiary care university teaching hospital for UAE. Forty-four participants were enrolled (mean age, 46 years; range, 32-56 years). ⋯ Of the 22 participants in the SHNB group, five (23%) needed antiemetics versus 12 of 22 participants (55%) in the sham group (P = .03). No difference in hospital admissions was observed between the two groups, and no major complications occurred from the SHNB. Conclusion Use of superior hypogastric nerve block reduces the amount of pain-related narcotics and antiemetics after uterine artery embolization. © RSNA, 2018.
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Randomized Controlled Trial Comparative Study
Digital Mammography versus Digital Mammography Plus Tomosynthesis for Breast Cancer Screening: The Reggio Emilia Tomosynthesis Randomized Trial.
Purpose To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods For this trial, eligible women (45-70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). ⋯ PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; -12 [95% CI: -68, 141]; for invasive cancers < 10 mm, 10-19 mm, and ≥ 20 mm, respectively). Conclusion DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.