Breast CancerMIBREASTNCT07136753
MIBREAST Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2024to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients considering breast reconstruction following mastectomy for cancer or risk reduction.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
London
Astrid Leusink, Astrid.Leusink@icr.ac.uk
Jennifer Rusby
About this study
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
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.
Read more
This study will investigate the following 3 questions:
- Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance
- 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
- 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:
- 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
- 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.
Read the 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
- Keywords
- Decision making, Reconstruction, Risk reducing surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Preioperative/Periprocedural
Secondary outcomes (9)
Difference in decisional conflict scale score
Difference in Decisional Conflict Scale (DCS) score for women who see and do not see their simulated reconstruction
Measured: Perioperative/Periprocedural
Comparison between 3D and SoC anthropometric measurements
Comparison between Crisalix and routine tape measure anthropometric measurements.The same unit of measurement will be used for the anthropometric distances (i.e.sternal notch to nippple, nipple to nipple, nipple to midline, nipple to lateral fold, nipple to inframammary fold and breast diameter) measured in cm for both 3D-SI and tape measurements
Measured: Perioperative/Periprocedural
Thematic analysis of surgeons' experience
Thematic analysis of surgeons' experience
Measured: 1 year
Evaluation of actual outcome against simulated appearance by panel assessment using a Likert scale
Evaluation of the actual outcome against the simulated appearance
Measured: 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
Comparison of patient satisfaction with the breast, and with information given (BREAST-Q domains) by randomisation group (3D simulation vs standard of care) at 1 and 2 years. To further undertake a panel assessment of 3D simulated outcomes and compare these to 2D images of actual post-operative appearance at 1 year after surgery. The panel will consist of consultant breast and plastic surgeons who will indicate likeness of simulated appearance to actual appearance on a Likert scale of 1-5 (score of 1 indicates that simulation is not at a similar to actual outcome and 5 indicates very similar appearance).
Measured: through study completion, an average of 1 year
Using 3D-SI to classify breast shape
Using 3D-SI to classify breast shape
Measured: through study completion, an average of 1 year
Impact of breast shape classification on elective secondary revisions (ESRs) and reconstructive outcomes
Impact of breast shape classification on elective secondary revisions (ESRs) and reconstructive outcomes. 3D-SI measurements (distances in cm and volume in cc) will be captured and using a principal component analysis different breast shape subgroups will be derived. Following this, to then compare breast shape type, primary surgery type (e.g. implant or autologous reconstruction) and whether the patient has had elective surgical revision. This will be an exploratory process to determine whether there is a relationship between breast shape and need for revision surgery. There is currently no existing tool to measure this. anthropometric measurements (sternal notch to nipple, nipple to nipple, nipple to inframammary fold, nipple to midline, nipple to lateral fold, breast diameter) are entered in cm and breast volume is entered in cc.
Measured: through study completion, an average of 1 year
Documented relationship between donor tissue availability and breast volume
The intend to examine the relationship between the available abdominal donor tissue and required breast volume for patients undergoing autologous breast reconstruction. A comparison of the available abdominal tissue (measured in cc) using manual segmentation of the CT scan and the required breast volume measured in cc on the pre-operative 3D-SI measurement. We would like to investigate whether a greater degree of mismatch (abdominal volume in cc divided by breast volume in cc) is related to an increased likelihood of requiring revisional surgery.
Measured: through study completion, an average of 1 year
Documented changes in shape of IBR with and without radiotherapy
volume Documented changes in shape of IBR with and without radiotherapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start12 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136753
- Sponsor's protocol ID
- CCR5635
- Acronym
- MIBREAST
- Status last verified
- Aug 2025
- First submitted
- 1 Feb 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07136753
- Acronym / sponsor ID
- MIBREAST / CCR5635
- Conditions
- Breast Cancer
- Keywords
- Decision making, Reconstruction, Risk reducing surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance
- 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
- 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:
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients considering breast reconstruction following mastectomy for cancer or risk reduction.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Visual Analogue Scale Score
Time frame: Preioperative/Periprocedural
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)
9 secondary outcomes
Difference in decisional conflict scale score
Time frame: Perioperative/Periprocedural
Comparison between 3D and SoC anthropometric measurements
Time frame: Perioperative/Periprocedural
Thematic analysis of surgeons' experience
Time frame: 1 year
Evaluation of actual outcome against simulated appearance by panel assessment using a Likert scale
Time frame: 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
Time frame: through study completion, an average of 1 year
Using 3D-SI to classify breast shape
Time frame: through study completion, an average of 1 year
Impact of breast shape classification on elective secondary revisions (ESRs) and reconstructive outcomes
Time frame: through study completion, an average of 1 year
Documented relationship between donor tissue availability and breast volume
Time frame: through study completion, an average of 1 year
Documented changes in shape of IBR with and without radiotherapy
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeane Guevara (+44 20 3186 5420, MIBREAST@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Visual Analogue Scale Score (time frame: Preioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.