MIBREAST

MIBREAST study – “ The IMpact of 3D Surface Imaging and Simulation on Shared Decision Making Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy

Overview

This is a single-centre study conducted at the Royal Marsden Hospital open to all women undergoing immediate breast reconstruction (IBR), both implant and autologous. The study comprises of three embedded sub-studies.

1. A Randomised Controlled Trial involving 170 participants, who are randomised 1:1 to either the intervention arm—viewing a bespoke 3D simulation of their own post-operative appearance—or the control arm, which involves standard-of-care verbal descriptions and viewing of 2D photos of patients who have had similar surgery. 
2. A 3D Surface Imaging-Based Analysis to develop a breast shape classification system and examine the relationship between breast shapes and the need for elective surgical revisions.
3. An Objective Evaluation of Radiotherapy Effects using 3D surface imaging (3D-SI) to compare patients who received radiotherapy (RT) before or after IBR with those who did not, to quantify radiotherapy-related changes in reconstructed breasts. 

As of December 2025, all 170 patients have been recruited to the RCT and a further 130 patients will be recruited to sub-study 2 and 3 (phase 2). Phase 2 of the study will open end of January 2026 and will likely complete recruitment by October 2026. 

Objectives

Primary objective:

• To understand whether women who see their own 3D simulation of their breast reconstruction feel more confident that they know how their breasts are likely to look after treatment compared to those who have not seen their own simulation using mean Visual Analogue Scale (VAS) answer to the question “How confident are you that you know how your breasts are likely to look after treatment?”

Secondary objectives:

• To investigate the difference in Decisional Conflict Scale score for women who see and do not see their simulated reconstruction
• To verify the agreement between Crisalix measurements of images acquired using the infra-red Structure Sensor and traditional tape measure anthropometric measurements routinely captured during the pre-operative outpatient appointment
• To gather qualitative data on clinician’s experience of real-time simulations
• To evaluate the impact of seeing one’s own simulation on satisfaction with breasts and information provided at one and two years
• To use 3D-SI to classify breast shape
• To investigate the impact of breast shape classification on elective secondary revisions (ESRs) and reconstructive outcomes
• To quantify the relationship between donor tissue availability and breast volume
• To quantify the impact of radiotherapy on immediate breast reconstruction

Inclusion/Exclusion criteria

Inclusion criteria include: 

• Female 
• Age > 18 years 
• Undergoing immediate breast reconstruction (autologous or implant based) following mastectomy for breast cancer or as a risk-reducing strategy 
• Available to attend 3D-SI appointments at specified intervals 

Exclusion criteria include:

• Lack of capacity 
• Language barrier that prevents patients from understanding the English questionnaires 
• Visual impairment 
• Unable to answer study questionnaires 
• Disability that may prevent appropriate positioning during the imaging process 
• Unable to attend for photography
• Requiring delayed reconstruction or no longer undergoing a reconstruction