Immediate breast reconstruction using 3D imaging and simulation to measure effects of radiotherapy
Official title: The IMpact of 3D Surface Imaging and Simulation on Shared Decision Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy
Run by Royal Marsden NHS Foundation Trust · NCT07136753 · Data updated 2026-11-12
This project will test whether 3D surface photos and simulated images help women having a mastectomy with immediate reconstruction feel more confident about their likely appearance, help surgeons plan to reduce later correction surgery, and measure how radiotherapy changes breast shape.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | September 12, 2024 |
| Main results expected | September 2026 |
| Study ends | September 2030 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT07136753 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (over 18) undergoing immediate breast reconstruction—implant or autologous—after mastectomy for cancer or risk reduction who can attend 3D imaging appointments and complete English questionnaires are ideal candidates.
✕Probably not a fit
Patients who are having delayed reconstruction, cannot attend in-person imaging, have significant visual or positioning limitations, lack capacity, or cannot complete English questionnaires are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will use 3D surface imaging (3D-SI) and computer simulation to show expected postoperative appearance and to take objective measurements of breast shape before and after immediate reconstruction. Participants include adult women undergoing mastectomy with immediate implant or autologous reconstruction who can attend scheduled imaging visits and complete questionnaires. Researchers will compare patient confidence, surgical planning decisions, and rates of later adjustment surgery, and will track changes in breast shape following radiotherapy. The approach combines patient-facing simulated images with quantitative 3D measurements to link expectations, surgical choices, and long-term aesthetic outcomes.
Why it matters
Potential benefit: If successful, the approach could improve patient expectations and satisfaction, help surgeons plan reconstructions that need fewer revision operations, and clarify how radiotherapy affects reconstructed breasts.
How similar studies have gone: 3D surface imaging and simulation are commonly used in cosmetic and reconstructive practice and smaller studies suggest they can aid expectations and planning, but large-scale evidence on reducing revision surgery and quantifying radiotherapy effects is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Aged \> 18 * Undergoing immediate breast reconstruction (autologous or implant based) follow mastectomy for breast cancer or as a risk-reducing strategy * Available to attend 3D-SI appointments at specified intervals Exclusion Criteria: * 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 considering a reconstruction
Where it's running
-
Royal Marsden NHS Foundation Trust
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Jeane Guevara
- Email: MIBREAST@rmh.nhs.uk
- Phone: +44 20 3186 5420
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.