MIBREAST Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy

NCT ID: NCT07136753

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2030-09-30

Brief Summary

Patients who require a removal of a breast (mastectomy) for breast cancer or future risk reduction often have immediate breast reconstruction (IBR). This can be performed using either an implant or the patient's own body fat to recreate the breast shape.

Patients can find it difficult to imagine their own post-surgery appearance. Using 3D surface imaging (3D-SI) can change a patient's pictures to show them how they might look after surgery, known as a simulation. Some patients may find 3D-SI and simulation gives them confidence in their expectations and others may not feel it helps much.

This study will investigate the following 3 questions:

1. Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance

2. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only

3. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up for some women who do and some who do not have radiotherapy after breast reconstruction.

3D surface imaging may improve surgeon understanding of breast shape, prior to surgery. In cases where there is a high risk of breast cancer recurrence patients are offered radiotherapy to the breast, either before or after surgery. Radiotherapy has a negative impact on the reconstructed breast, and may cause it to shrink and change position but the effect of radiotherapy has never been accurately quantified. This study will be investigating the following:

1. Whether 3D-SI measurement of breast shape helps in surgical planning and reduces the need for later adjustment surgery to improve symmetry, especially in patients having a mastectomy on one side only

2. How much radiotherapy changes breast reconstructions over time using 3D- SI to objectively measure this. For this study the follow up some women who do and some who do not have radiotherapy after breast reconstruction.

Detailed Description

Approximately 40% of all women diagnosed with breast cancer (BC) will require a mastectomy and a large proportion (60%) of these will choose to have an immediate breast reconstruction (IBR).

Patient satisfaction with physical appearance after completion of their BC treatment has a well-documented association not only with their psychological wellbeing but also improved quality of life. Due to advances in oncological therapies, BC patients now have excellent survival rates of 85% at five years and 75% at ten years meaning that more women survive to experience the long-term impact of surgical and radiotherapy treatments and highlights the importance of improving aesthetic outcome as a survivorship focus.

3D-surface imaging (3D-SI) and simulation is frequently used to demonstrate cosmetic breast augmentation outcomes in the private sector and is increasingly being used in breast cancer surgery.

Effective communication of the post-operative aesthetic outcome and the possible requirement of adjustment surgery to patients is a central part of the informed consent process. Women sometimes struggle to decide between breast-conserving treatment and mastectomy with or without reconstruction. Those that want reconstruction to have the option of using a silicone implant, or their own tissue, transplanted from the abdomen or inner thigh (an autologous flap). Consultations focus on the patient's desires and expectations, and the surgeon's explanation of what is technically possible, the benefits and compromises, until a mutual understanding is reached. This can however be challenging, particularly when attempting to predict the effects of adjuvant radiotherapy on the reconstructed breast. Traditionally, surgeons have used diagrams or 2D clinical photographs of other patients who have had surgery to demonstrate the predicted post-operative appearance. Many patients have reported that they find these methods unhelpful and confusing, as the wide variety of body habitus, breast shape, skin tone and surgical options mean that it is unlikely that a woman will see images adequately illustrating her own unique outcome.

The hypothesise that viewing 3D simulations of their own likely appearance after mastectomy and breast reconstruction will give women more confidence and certainty as they approach surgery. There are not yet in a position to use 3D-SI as a decision-support tool.

The overarching aim of this study is to evaluate the utility of 3D-SI in simulation and measurement of outcome of immediate breast reconstruction.

Hypothesis 1 - Impact of 3D Simulation on Shared Decision Making Women who see a simulation of their IBR outcome will have more confidence in their decision-making about IBR options.

Hypothesis 2 - Impact of 3D-SI on Elective Surgical Revision rate A better understanding of breast shape may reduce the need for elective surgical revisions such as volume-adjustment procedures (lipofilling or liposuction) in the reconstructed breast.

Hypothesis 3 - Impact of Radiotherapy on IBR The hypothesise that immediate breast reconstructions that receive radiotherapy undergo greater change in shape and position over time.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of Care

2D catalogue of photographs of other patients who have had surgery to demonstrate the predicted post-operative appearance

No interventions assigned to this group

3D Surface Imaging

3D Simulation of patients own breast to show them how they might look after surgery

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jeane Guevara

Role: CONTACT

MIBREAST@rmh.nhs.uk

+44 20 3186 5420

Facility Contacts

Astrid Leusink

Role: primary

Astrid.Leusink@icr.ac.uk

Other Identifiers

CCR5635

Identifier Type: -

Identifier Source: org_study_id