MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials.

Background Several early-phase clinical trials for the treatment of nonalcoholic steatohepatitis (NASH) use liver fat content as measured with the MRI-derived proton density fat fraction (PDFF) for a primary outcome. These trials have shown relative reductions in liver fat content with placebo treatment alone, a phenomenon termed "the placebo effect." This phenomenon confounds the results and limits generalizability to future trials. Purpose To quantify the effect of placebo treatment on change in the absolute PDFF value and to identify variables associated with this observed change. Materials and Methods This is a secondary analysis of prospectively collected data from seven early phase clinical trials that included participants with a diagnosis of NASH based on MRI and/or liver biopsy who received placebo treatment. The primary outcome was a greater than or equal to 30% relative reduction in PDFF after placebo treatment. Normalization of PDFF, relative change in alanine aminotransferase (ALT) level, and normalization of ALT level were also examined. An exploratory linear mixed-effects model was used to estimate an overall change in absolute PDFF and to explore parameters associated with this response. Results A total of 187 participants (median age, 52 years [IQR, 43-60 years]; 114 women) who received placebo treatment were evaluated. A greater than or equal to 30% relative reduction in baseline PDFF was seen in 20% of participants after 12 weeks of placebo treatment (10 of 49), 9% of participants after 16 weeks (two of 22), and 28% of participants after 24 weeks (34 of 122). A repeated-measures linear mixed-effects model estimated a decrease of 2.3 units (median relative reduction of 13%) in absolute PDFF values after 24 weeks of placebo treatment (95% CI: 3.2, 1.4; P < .001). Conclusion In this analysis of 187 participants, a clinically relevant decrease in PDFF was observed with placebo treatment. Based on the study model, assuming an absolute PDFF decrease of approximately 3 units (upper limit of 95% CI) to account for this "placebo effect" in sample size calculations for future clinical trials is suggested. Clinical trial registration nos. NCT01066364, NCT01766713, NCT01963845, NCT02443116, NCT02546609, NCT02316717, and NCT02442687 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Yoon in this issue.

Now or Later? Patient Satisfaction and Anxiety Among Women Undergoing Breast Biopsies Performed the Same Day as Recommended Versus a Later Day.

PURPOSE: The aim of this study was to determine differences in patient satisfaction and anxiety among women undergoing core-needle breast biopsies performed the same day as recommended versus a future date. METHODS: After institutional review board exemption was granted, a survey was administered to patients at four sites on the day of imaging-guided core-needle breast biopsy. The survey was available from November 2020 through January 2022. Questions pertained to biopsy timing (same day versus later day), pre- and postbiopsy satisfaction with overall breast-care experience, biopsy wait-time satisfaction, pre- and postbiopsy anxiety, radiologist-patient communication, demographics, life stressors, breast cancer history, and risk factors. Comparisons were made between same-day and later-day biopsies by multivariable analysis. RESULTS: Of 974 respondents (response rate 65.6%), almost half were scheduled for same-day biopsies (47.8% [466 of 974]). In multivariate analyses, same-day biopsies were associated with higher prebiopsy overall breast-care satisfaction (P < .001), higher wait-time satisfaction (P < .001), and higher prebiopsy (P = .001) and postbiopsy anxiety (P = .001). Better radiologist-patient communication was associated with lower prebiopsy anxiety (P < .001) and greater prebiopsy overall (P < .001) and wait-time (P < .001) satisfaction. Compared with White women, Black women reported lower postbiopsy anxiety (P < .001) but also lower prebiopsy satisfaction (P = .03) and wait-time satisfaction (P < .001). CONCLUSIONS: Same-day versus later-day biopsies resulted in better prebiopsy overall breast-care and wait-time patient satisfaction scores; however, no satisfaction differences were noted after biopsy. Clinically significant anxiety was associated with both same- and later-day biopsies but was higher for same-day biopsies. Higher anxiety levels correlated with lower overall satisfaction, suggesting that interventions to reduce anxiety and improve communication could improve patient experiences during same-day biopsies.

CT-derived body composition measurements as predictors for neoadjuvant treatment tolerance and survival in gastroesophageal adenocarcinoma.

PURPOSE: Treatment for gastroesophageal adenocarcinomas can result in significant morbidity and mortality. The purpose of this study is to supplement methods for choosing treatment strategy by assessing the relationship between CT-derived body composition, patient, and tumor features, and clinical outcomes in this population. METHODS: Patients with neoadjuvant treatment, biopsy-proven gastroesophageal adenocarcinoma, and initial staging CTs were retrospectively identified from institutional clinic encounters between 2000 and 2019. Details about patient, disease, treatment, and outcomes (including therapy tolerance and survival) were extracted from electronic medical records. A deep learning semantic segmentation algorithm was utilized to measure cross-sectional areas of skeletal muscle (SM), visceral fat (VF), and subcutaneous fat (SF) at the L3 vertebra level on staging CTs. Univariate and multivariate analyses were performed to assess the relationships between predictors and outcomes. RESULTS: 142 patients were evaluated. Median survival was 52 months. Univariate and multivariate analysis showed significant associations between treatment tolerance and SM and VF area, SM to fat and VF to SF ratios, and skeletal muscle index (SMI) (p = 0.004-0.04). Increased survival was associated with increased body mass index (BMI) (p = 0.01) and increased SMI (p = 0.004). A multivariate Cox model consisting of BMI, SMI, age, gender, and stage demonstrated that patients in the high-risk group had significantly lower survival (HR = 1.77, 95% CI = 1.13-2.78, p = 0.008). CONCLUSION: CT-based measures of body composition in patients with gastroesophageal adenocarcinoma may be independent predictors of treatment complications and survival and can supplement methods for assessing functional status during treatment planning.