Augmented Reality Guided Needle Biopsy of Soft Tissue: A Pilot Study.

Percutaneous biopsies are popular for extracting suspicious tissue formations (primarily for cancer diagnosis purposes) due to the: relatively low cost, minimal invasiveness, quick procedure times, and low risk for the patient. Despite the advantages provided by percutaneous biopsies, poor needle and tumor visualization is a problem that can result in the clinicians classifying the tumor as benign when it was malignant (false negative). The system developed by the authors aims to address the concern of poor needle and tumor visualization through two virtualization setups. This system is designed to track and visualize the needle and tumor in three-dimensional space using an electromagnetic tracking system. User trials were conducted in which the 10 participants, who were not medically trained, performed a total of 6 tests, each guiding the biopsy needle to the desired location. The users guided the biopsy needle to the desired point on an artificial spherical tumor (diameters of 30, 20, and 10 mm) using the 3D augmented reality (AR) overlay for three trials and a projection on a second monitor (TV) for the other three trials. From the randomized trials, it was found that the participants were able to guide the needle tip 6.5 ± 3.3 mm away from the desired position with an angle deviation of 1.96 ± 1.10° in the AR trials, compared to values of 4.5 ± 2.3 mm and 2.70 ± 1.67° in the TV trials. The results indicate that for simple stationary surgical procedures, an AR display is non-inferior a TV display.

Long-term Effects of Moderate versus High Durations of Aerobic Exercise on Biomarkers of Breast Cancer Risk: Follow-up to a Randomized Controlled Trial.

BACKGROUND: The optimal lifestyle for breast cancer prevention over the long term is unclear. We aimed to determine whether or not the amount of exercise prescribed in a year-long exercise intervention influences breast cancer biomarker levels 1 year later. METHODS: We conducted a 24-month follow-up study (2012-2014) to the Breast Cancer and Exercise Trial in Alberta (BETA), a 12-month, two-armed (1:1), two-center randomized controlled trial of exercise in 400 cancer-free, postmenopausal women. The exercise prescription was moderate-vigorous aerobic exercise, 5 days/week (3 days/week supervised) for 30 minutes/session (MODERATE) or 60 minutes/session (HIGH). Participants were asked not to change their usual diet. We used linear mixed models to compare biomarker concentrations (C-reactive protein, insulin, glucose, HOMA-IR, estrone, sex hormone binding globulin, total estradiol, and free estradiol) over time (0, 12, and 24 months) by group (MODERATE, HIGH), using group-time interactions. RESULTS: After 12 months of no intervention, 24-month fasting blood samples were available for 84.0% and 82.5% of MODERATE and HIGH groups, respectively (n = 333/400). We found no evidence that 0 to 24- or 12 to 24-month biomarker changes differed significantly between randomized groups (HIGH:MODERATE ratio of mean biomarker change ranged from 0.97 to 1.06, P values >0.05 for all). We found more favorable biomarker profiles among participants who experienced greater than the median fat loss during the trial. CONCLUSIONS: Prescribing aerobic exercise for 300 versus 150 minutes/week for 12 months to inactive, postmenopausal women had no effects on longer-term biomarkers. IMPACT: Exercise may lead to larger improvements in breast cancer biomarkers after intervention among women who also experience fat loss with exercise.

Exercise Dose Effects on Body Fat 12 Months after an Exercise Intervention: Follow-up from a Randomized Controlled Trial.

Background: Exercise interventions can result in weight loss, which is associated with reductions in disease risk. It is unknown how the volume of exercise prescribed in a one-time exercise intervention impacts long-term body fatness. We compared 24-month body fat changes among postmenopausal women previously prescribed 300 versus 150 minutes/week of exercise in a year-long exercise intervention trial. Methods: The Breast Cancer and Exercise Trial in Alberta (BETA) was a two-centred randomized controlled trial in Alberta, Canada. The trial consisted of a 12-month intervention and 12-month observation period. For the intervention, participants were randomized to either a moderate-volume exercise group (150 min/week) or a high-volume exercise group (300 min/week). Participants in this study were 334 inactive postmenopausal women who had been followed-up to 24 months. The primary outcome for this study was 24-month change in total body fat using dual energy X-ray absorptiometry scans. Other measures included weight, waist and hip circumferences, subcutaneous and intra-abdominal fat from computed tomography scans, and lean mass. Researchers were blinded to randomization group when measuring body fat. Results: Both groups self-reported ∼180 minutes/week moderate-vigorous activity at 24 months. No statistically significant difference was found in total body fat at 24 months between the two groups. Statistically significant effects (comparing high versus moderate groups) were found for BMI (least-square mean change (95% CI): -0.66 (-0.97, -0.36) versus -0.25 (-0.55, 0.05) kg/m2, P=0.04), waist-to-hip ratio (-0.033 (-0.040, -0.026) versus -0.023 (-0.030, -0.016), P=0.05), and subcutaneous abdominal fat area (-32.18 (-39.30, -25.06) versus -22.20 (-29.34, -15.05) cm2, P=0.04). Conclusion: Prescribing 300 versus 150 minutes/week of exercise to inactive postmenopausal women resulted in some long-term greater decreases in measures of body composition but no overall differences in total body fat loss. This trail is registered with NCT01435005.

Effects of exercise dose on endogenous estrogens in postmenopausal women: a randomized trial.

Exercise dose comparison trials with biomarker outcomes can identify the amount of exercise required to reduce breast cancer risk and also strengthen the causal inference between physical activity and breast cancer. The Breast Cancer and Exercise Trial in Alberta (BETA) tested whether or not greater changes in estradiol (E2), estrone, and sex hormone-binding globulin (SHBG) concentrations can be achieved in postmenopausal women randomized to 12 months of HIGH (300 min/week) vs MODERATE (150 min/week) volumes of aerobic exercise. BETA included 400 inactive postmenopausal women aged 50-74 years with BMI of 22-40 kg/m(2). Blood was drawn at baseline and 6 and 12 months. Adiposity, physical fitness, diet, and total physical activity were assessed at baseline and 12 months. Intention-to-treat analyses were performed using linear mixed models. At full prescription, women exercised more in the HIGH vs MODERATE group (median min/week (quartiles 1,3): 253 (157 289) vs 137 (111 150); P<0.0001). Twelve-month changes in estrogens and SHBG were <10% on average for both groups. No group differences were found for E2, estrone, SHBG or free E2 changes (treatment effect ratios (95% CI) from linear mixed models: 1.00 (0.96-1.06), 1.02 (0.98-1.05), 0.99 (0.96-1.02), 1.01 (0.95, 1.06), respectively, representing the HIGH:MODERATE ratio of geometric mean biomarker levels over 12 months; n=382). In per-protocol analyses, borderline significantly greater decreases in total and free E2 occurred in the HIGH group. Overall, no dose effect was observed for women randomized to 300 vs 150 min/week of moderate to vigorous intensity exercise who actually performed a median of 253 vs 137 min/week. For total and free E2, the lack of differential effect may be due to modest adherence in the higher dose group.

Effects of a High vs Moderate Volume of Aerobic Exercise on Adiposity Outcomes in Postmenopausal Women: A Randomized Clinical Trial.

IMPORTANCE: Body fat increases postmenopausal breast cancer risk. Physical activity may decrease risk through adiposity changes, but the optimal dose of activity is unknown. OBJECTIVE: To compare the effects of 300 vs 150 min/wk of moderate to vigorous aerobic exercise on body fat in postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: The Breast Cancer and Exercise Trial in Alberta was a 12-month, 2-armed, 2-center randomized dose-comparison trial conducted from June 2010 through June 2013. Participants were 400 inactive postmenopausal women with body mass index 22 to 40, disease-free, nonsmokers, and nonusers of exogenous hormones. INTERVENTIONS: Five d/wk of aerobic exercise (3 d/wk supervised, 2 d/wk unsupervised) for 30 min/session (moderate-volume) or 60 min/session (high volume) achieving 65% to 75% of heart rate reserve for at least 50% of each session. Participants were asked not to change usual diet. MAIN OUTCOMES AND MEASURES: Total body fat, measured from dual energy x-ray absorptiometry scans, was the primary outcome. Other measures included subcutaneous and intra-abdominal fat from computed tomography scans, weight, and waist and hip circumferences. RESULTS: Of 400 women, 384 provided baseline and follow-up adiposity measurements. Median (interquartile range) adherence at full prescription for the high- and moderate-volume groups was 254 (166-290) and 137 (111-150) min/wk, respectively. Mean reductions in total fat were significantly larger in the high- vs moderate-volume group (least-squares mean difference, -1.0% [95% CI, -1.6% to -0.4%], P = .002). Subcutaneous abdominal fat and waist to hip ratio decreased significantly more in the high-volume group (least-squares mean difference, -10.8 [95% CI, -19.5 to -2.2] cm², P = .01, and -0.01 [95% CI, -0.02 to 0.00], P = .04, respectively). Changes in weight and intra-abdominal fat were not significantly different between groups (least-squares mean difference, -0.7 [95% CI, -1.6 to 0.2] kg, P = .11, and -1.5 [95% CI, -5.9 to 2.9] cm², P = .50, respectively). Some dose-response effects were stronger for obese women. CONCLUSIONS AND RELEVANCE: In previously inactive postmenopausal women, a 1-year prescription of moderate to vigorous exercise for 300 min/wk was superior to 150 min/wk for reducing total fat and other adiposity measures, especially in obese women. These results suggest additional benefit of higher-volume aerobic exercise for adiposity outcomes and possibly a lower risk of postmenopausal breast cancer. TRIAL REGISTRATION: clinicaltrials.gov: NCT01435005.

Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA).

BACKGROUND: Exercise has favorable effects on biomarkers associated with a lower risk of breast cancer, however it is unclear if higher doses of exercise provide additional effects. No clinical trial has systematically examined how different exercise volumes influence the mechanisms underlying breast cancer etiology. The Breast Cancer and Exercise Trial in Alberta (BETA) - a follow-up study to the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial - is examining how a one-year, high versus moderate volume aerobic exercise intervention influences several biomechanisms hypothesized to influence breast cancer risk in a group of postmenopausal women. Secondary aims are to compare intervention effects on psychosocial and quality of life outcomes as well as understand exercise adherence at 12 and 24 months, and maintenance of all study outcomes at 24 months. METHODS/DESIGN: The BETA Trial is a two-center, two-armed randomized controlled exercise intervention trial conducted in 400 previously inactive, postmenopausal women aged 50-74 years, in Alberta, Canada. Participants were randomly assigned to a one-year aerobic exercise intervention of either high volume (300 minutes/week) or moderate volume (150 minutes/week). Blood draws and accelerometry were performed at baseline, six and 12 months. Baseline and 12-month measurements were taken of adiposity (including dual energy X-ray absorptiometry and computed tomography scans), physical fitness, dietary intake, self-reported physical activity and sedentary behavior, quality of life, perceived stress, happiness, sleep, and determinants of exercise adherence. Exercise maintenance was assessed and all study measurements were repeated at 24 months. Blood will be analyzed for endogenous estrogens, insulin resistance indicators, and inflammatory markers. DISCUSSION: The BETA Trial will compare the impact of a high versus moderate volume of aerobic exercise on a variety of biological, physiological, and psychological outcomes of relevance to postmenopausal women. A tightly controlled exercise intervention and objective outcome measurements are methodological strengths. The BETA Trial will inform future prevention initiatives by assessing adherence to a high volume of exercise over 12 months by postmenopausal women, and the ability of these women to maintain activity over the longer-term. The ultimate objective is to inform public health guidelines for reducing breast cancer risk through physical activity. CLINICAL TRIALS REGISTRATION NUMBER: NCT01435005.