Designing a breast support device for phase contrast tomographic imaging : getting ready for a clinical trial

Objective To design a device that can support the breast during phase-contrast tomography, and characterise its fit parameterisation and comfort rating. Methods 27 participants were recruited to trial a system for breast support during simulated phase contrast imaging, including being positioned on a prone imaging table while wearing the device. Participants underwent a photogrammetry analysis to establish the geometric parameterisations. All participants trialled a single-cup design while 14 participants also trialled a double-cup with suction holder and all completed a series of questionnaires to understand subjective comfort. Results Photogrammetry revealed significant positive correlations between bra cup volume and measured prone volume (p < 0.001), and between “best fit” single-cup holder volume and measured prone volume (p < 0.005). Both holders were suitable devices in terms of subjective comfort and immobilisation while stationary. However, some re-engineering to allow for quick, easy fitting in future trials where rotation through the radiation beam will occur is necessary. Light suction was well-tolerated when required. Conclusion All participants indicated the table and breast support devices were comfortable, and they would continue in the trial. Advances in knowledge Phase contrast tomography is an emerging breast imaging modality and clinical trials are commencing internationally. This paper describes the biomedical engineering designs, in parallel with optimal imaging, that are necessary to measure breast volume so that adequate breast support can be achieved. Breast support devices have implications for comfort, motion correction and maximising breast tissue visualisation.