scholarly journals MRI versus mammography plus ultrasound in women at intermediate breast cancer risk: study design and protocol of the MRIB multicentre randomized controlled trial

Author(s):  
Luigina Ada Bonelli ◽  
Massimo Calabrese ◽  
Paolo Belli ◽  
Stefano Corcione ◽  
Claudio Losio ◽  
...  

AbstractBackgroundIn women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ±ultrasound (Mx±US) increases sensitivity but decreases specificity. An alternative strategy, MRI alone, potentially more cost-effective, has never been explored. This study aims to assess the characteristics of women who participated in a randomized trial offering MRI alone.MethodsIn this feasibility multicentre randomized controlled trial we compared MRI alone versus Mx+US in women at intermediate BC-risk (allocation ratio 1:1). Eligible women were aged 40 –59, with a 15–30% LTR and/or extremely dense breasts. Two screening rounds per woman were planned in ten centres experienced in MRI screening. Primary endpoint: rate of cancers detected in the two arms after 5 years of follow-up. Secondary endpoints: distribution of the risk profiles among the women enrolled in the trial; distribution of pathological stages and histology of cancers detected; interval cancer rate in the two arms.ResultsFrom 07/2013 to 11/2015, 1,254 women (mean age 47 years) were enrolled: 624 were assigned to Mx+US, 630 to MRI. Most of them were aged below 50 (72%) and premenopausal (45%), 52% used oral contraceptives. Among postmenopausal women, 15% had used hormone replacement therapy. Breast and/or ovarian cancer in mother and/or sisters were reported by 37% of enrolled women, extreme breast density was recorded for 79%, 41% had a 15–30% BC-LTR.ConclusionsThe distribution of BC-risk profile major determinants (breast density and family of breast and ovarian cancer) of enrolled women varied across centres.Trial registrationNCT02210546Key pointsMammography plus ultrasound are commonly used to screen women with dense breastsSupplemental ultrasound increases BC detection rate but also false-positives and potential overdiagnosisWhether increased BC detection by US translates into reduced mortality is unknownMRI alone could be more risk- and cost-effective than mammography plus ultrasound

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1635
Author(s):  
Luigina Ada Bonelli ◽  
Massimo Calabrese ◽  
Paolo Belli ◽  
Stefano Corcione ◽  
Claudio Losio ◽  
...  

In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strategy. Here, we describe the study protocol and the characteristics of enrolled patients for MRIB feasibility, multicenter, randomized, controlled trial, which aims to compare MRI alone versus MX+US in women at intermediate breast cancer risk (aged 40–59, with a 15–30% BC-LTR and/or extremely dense breasts). Two screening rounds per woman were planned in ten centers experienced in MRI screening, the primary endpoint being the rate of cancers detected in the 2 arms after 5 years of follow-up. From July 2013 to November 2015, 1254 women (mean age 47 years) were enrolled: 624 were assigned to MX+US and 630 to MRI. Most of them were aged below 50 (72%) and premenopausal (45%), and 52% used oral contraceptives. Among postmenopausal women, 15% had used hormone replacement therapy. Breast and/or ovarian cancer in mothers and/or sisters were reported by 37% of enrolled women, 79% had extremely dense breasts, and 41% had a 15–30% BC-LTR. The distribution of the major determinants of breast cancer risk profiles (breast density and family history of breast and ovarian cancer) of enrolled women varied across centers.


BMC Cancer ◽  
2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Sepideh Saadatmand ◽  
Emiel J T Rutgers ◽  
RobAEM Tollenaar ◽  
Hermien M Zonderland ◽  
MargreetGEM Ausems ◽  
...  

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.


2008 ◽  
Vol 35 (1) ◽  
pp. 116-122 ◽  
Author(s):  
Kerry S. Courneya ◽  
Donald C. McKenzie ◽  
Robert D. Reid ◽  
John R. Mackey ◽  
Karen Gelmon ◽  
...  

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