Senosense Study: Breast density measured using electrical impedance
Research type
Research Study
Full title
Senosense Study: Menstrual cycle related fluctuations in breast density measured using electrical impedance.
IRAS ID
130266
Contact name
Anthony Howell
Contact email
Research summary
In order to develop new drugs to prevent breast cancer we need to be able to measure their effect on the breast. We have previously shown that tamoxifen is only effective for the prevention of breast cancer in women who have a reduction of breast density over a period of 18 months(Cuzick et al JNCI 2011). Thus, measurement of change of density appears to be a surrogate for the effectiveness of tamoxifen for prevention. However, because of the radiation risk mammography for screening is not permitted at less than one year intervals. We need a method to determine breast change and drug responsiveness in a shorter time period in order reduce the period of unnecessary drug exposure and to speed up preventive drug discovery. Here we wish to perform pilot studies to assess the value of bio-electrical impedance to measure change in the breast which might predict the effectiveness of of preventive therapies in a short time frame. Just as there is a significant difference in the X-Ray absorption in mammography of adipose and epithelial tissue, there is also a significant difference in their electrical characteristics. Epithelial and stromal tissues, which constitute the white appearing ‘dense tissue’ on a mammogram, have approximately 1/8th the electrical impedance value of adipose tissue which appears translucent/dark. Impedance is already used to measure body fat as opposed to non-fatty tissues such as muscle and bone. Here we will test a device to assess impedance on the breast only. When measured by mammography and breast magnetic resonance imaging there is an increase in breast density in the second half of the menstrual cycle under the influence of luteal progesterone. We will assess the effectiveness of the senoSENSE bio-impedance device to detect this increase in breast density. Ten volunteers with normal length menstrual cycles will be asked to have bio-electrical impedence measured in both breasts twice a week for two months. This is a pilot study: a positive result will lead to further investigation of the senoSENSE device for drug development and evaluation of breast density.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0094
Date of REC Opinion
7 May 2014
REC opinion
Further Information Favourable Opinion