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

NCT07136753 | Recruiting

• 1 other identifier: CCR5635
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 1.Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance
2. 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. 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.
4. 4.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
5. 5.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.

Conditions

Breast Cancer

Keywords

Decision making; Reconstruction; Risk reducing surgery

Outcome Measures

Primary Outcomes (1)

• Difference in Visual Analogue Scale Score

  Difference in mean visual analogue scale (VAS) for the question 'How confident is one in knowing how their breasts are likely to look after treatment?' VAS score is on a scale from 0-10 (0 indicates not at all confident and 10 indicates very confident)

  Preioperative/Periprocedural

Secondary Outcomes (9)

• Difference in decisional conflict scale score

  Perioperative/Periprocedural

• Comparison between 3D and SoC anthropometric measurements

  Perioperative/Periprocedural

• Thematic analysis of surgeons' experience

  1 year

• Evaluation of actual outcome against simulated appearance by panel assessment using a Likert scale

  through study completion, an average of 1 year

• Comparison of patient satisfaction with the breast, and with information given (BREAST-Q domains) by randomisation group

  through study completion, an average of 1 year

Study Arms (2)

Standard of Care

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

3D Surface Imaging

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female participants only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients considering breast reconstruction following mastectomy for cancer or risk reduction.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jeane Guevara

CONTACT

+44 20 3186 5420; MIBREAST@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: August 22, 2025
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)