How does 3D-SI work?
The Crisalix system is the first cloud-based 3D breast imaging system. The patient’s images are captured using a sensor attached to an iPad that casts infrared dots onto the patients torso, from which a 3D image is created. The 3D image is then altered to demonstrate the possible post-surgery appearance.
The images do not include any identifiable features (such as your face) and will be securely stored under your unique study ID. No identifiable information will be stored on the Crisalix portal.
The MIBREAST study will ask a subgroup of women to upload their own 2D “selfies” to the Crisalix portal, from which 3D images can be created. We will investigate whether this method is as accurate and acceptable as using the infra-red camera which is hospital-based, as this may help improve the convenience of future image capturing.
3D-surface imaging is safe
With no known side-effects, the 3D simulation is however a mere “best estimate” of your possible post-surgery appearance and your actual outcome may be better or worse than the simulated outcome.
Images will not include any identifiable features (such as your face) and will be securely stored under your unique study ID. No identifiable information will be stored on the Crisalix portal.
We hope that this study will help us obtain the information needed to understand whether all patients should be offered the opportunity to see a simulated image of their opwn reconstruction in preparation for surgery. This study will also help surgeons understand surgical techniques and measure the effects of radiotherapy to help improve the cosmetic outcomes for patients undergoing a mastectomy and breast reconstruction.
What does the study involve?
Some participants will be involved in all three parts of the study and some only in the second and third part of the study. Recruitment for the second and third parts of the study are currently underway, and we are expecting to open the first part of the study to recruitment soon.
Women who are invited and agree to participate in the first part of the study, will join one of two groups, half will receive the standard information about their likely post-surgery appearance and half will, in addition, get to see the 3D simulation. The allocation to groups is done by computer in a process called randomisation. Neither you nor your surgeon is allowed to choose which group you are in. Randomisation is necessary to ensure that results are due to the 3D-SI and simulation alone, and not any other factor. Those on the group who do not get to see their images will be no worse off as they will still receive the usual standard of care.
We will ask you to complete online questionnaires and complete 3D-SI photography before your surgery, as well as at 6 weeks, 3 months, 12 months, and 24 months after your surgery. The questionnaires do not take long to complete, and this can be done from the comfort of your own home. The photography appointments can be scheduled via the website, to ensure your images are captured swiftly, often coordinated with your usual clinic or treatment appointments.
If you only participate in the second and third part of the study will be asked to have the 3D-SI photography and complete the BREAST-Q questionnaires in the same time frames as the first part of the study.
Remember: most 3D-SI appointments can be scheduled to be coordinated your other routine clinical appointments to make this as easy for you as possible!
We hope that this study will help us obtain the information needed to understand whether all women should be offered the opportunity to see a simulated image of their own reconstruction in preparation for surgery. This study will also help surgeons analyse surgical techniques and measure the effects of radiotherapy to help improve the cosmetic outcomes for future patients undergoing mastectomy and breast reconstruction.
The MIBREAST study consists of 3 parts and will be investigating the following:
1
Patient confidence
Whether 3D-SI and simulation improves women’s confidence about their post-surgery appearance to address their information needs as outlined above.
2
The need for more surgery
Whether 3D-SI measurement of breast shape can help surgeons with planning surgery and potentially reduce the need for later adjustment surgery (particularly to improve symmetry in women having surgery on side only)
3
Impact of radiotherapy
How much radiotherapy changes the breast reconstruction over time and using 3D-SI to capture and objectively measure this by comparing images of women who do have radiotherapy with women who do not.
1
2
The need for more surgery
Whether 3D-SI measurement of breast shape can help surgeons with planning surgery and potentially reduce the need for later adjustment surgery (particularly to improve symmetry in women having surgery on side only)
Impact of radiotherapy
How much radiotherapy changes the breast reconstruction over time and using 3D-SI to capture and objectively measure this by comparing images of women who do have radiotherapy with women who do not.
3
Whether 3D-SI and simulation improves women’s confidence about their post-surgery appearance to address their information needs as outlined above.