RecruitingOBSERVATIONAL

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

This study, called MIBREAST, aims to understand how 3D imaging can help women having breast reconstruction after a mastectomy for breast cancer or to reduce their future risk. Many women find it hard to imagine how they will look after surgery. This research will explore whether showing them a 3D picture of their possible new appearance makes them feel more confident and helps them prepare. Researchers also want to see if this imaging can help surgeons plan the operation better, potentially reducing the need for further surgery to make breasts more even. Finally, the study will measure how much radiotherapy affects reconstructed breasts over time using 3D imaging, as this hasn't been properly understood before.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

300

Start

12 Sep 2024

Estimated completion

01 Sep 2030

Breast Cancer

What is this study about?

When women need to have a breast removed (mastectomy) due to breast cancer or to lower their risk, they can often choose to have a new breast shape created at the same time. This is called immediately breast reconstruction. This can be done using a breast implant or by taking some of their own body tissue from another part of their body.

It can be quite difficult for patients to imagine how they will look after this surgery. This study is testing if a special 3D camera and computer program can help. This technology can take pictures of a patient and then change them to show a possible 'before and after' image. The researchers want to know if seeing these simulated pictures helps women feel more sure about their choices and more prepared for their new appearance. They are also investigating if this 3D imaging can help surgeons plan the operation more precisely, especially if someone is only having one breast reconstructed, which could reduce the need for further surgeries to make things look more balanced.

A really important part of this study is looking at how radiotherapy affects reconstructed breasts. Radiotherapy is often given after breast cancer surgery to help prevent the cancer from coming back, but it can sometimes cause the reconstructed breast to shrink or change shape. Currently, we don't fully understand how much radiotherapy changes the breast over time. This study will use the 3D imaging to accurately measure these changes in women who have radiotherapy and compare them to women who don't, helping us to get a clearer picture of its long-term effects.

Key takeaways

Uses 3D imaging to help patients visualize breast reconstruction.
Aims to boost patient confidence about post-surgery appearance.
Investigates if 3D imaging improves surgical planning and symmetry.
Measures how radiotherapy affects reconstructed breasts over time.
No new treatments or drugs are being tested.
Your participation could help improve care for future patients.

Who may be eligible?

This study is looking for women who are 18 years or older and are planning to have a breast removed (mastectomy) and an immediate breast reconstruction. This might be because they have breast cancer or are having the surgery to significantly reduce their risk of getting breast cancer in the future. The reconstruction can be either using an implant or their own body tissue.

To take part, you need to be able to attend regular appointments for 3D imaging. You also need to be able to understand questionnaires in English and have good eyesight. If you have any disability that would make it difficult to stand in a certain position for the imaging, or if you are not planning an immediate reconstruction, then this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and over 18?
Are you having a mastectomy and immediate breast reconstruction?
Can you understand and answer questions in English?
Can you attend appointments for 3D imaging?
Are you able to stand in a specific position for imaging?

Answer every question to see your result.

What does participation involve?

If you join this study, you would attend regular appointments where 3D pictures of your chest would be taken. These imaging sessions would happen at specific times throughout your treatment and recovery. You would also be asked to complete questionnaires to share your thoughts and feelings about your new appearance and overall experience. The study will follow you over time to see how your reconstructed breast changes, especially in relation to radiotherapy. The total duration of your involvement would depend on your individual treatment plan, including whether you have radiotherapy, as some women will be followed for longer to track its effects.

Potential risks and benefits

Participating in this study might offer you the benefit of seeing a simulated image of your post-surgery appearance, which could help you feel more confident and informed about your reconstruction. Your involvement will also provide valuable information that could improve planning for future patients and help us better understand the effects of radiotherapy on reconstructed breasts. The risks are minimal and mainly involve the time commitment for appointments and completing questionnaires. There are no medical interventions being tested. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 3D surface imaging?

It's a special camera system that takes detailed 3D pictures of your body, which can then be used to show how you might look after surgery.

Will this study affect my breast reconstruction surgery?

No, the study will not change how your surgery is performed. It aims to see if the imaging helps you and your surgical team with planning and understanding.

What if I decide not to have radiotherapy?

That's fine. The study is following both women who have radiotherapy and those who don't, to compare the effects.

How long will I be in the study?

Your involvement length depends on your treatment, especially if you have radiotherapy, as the study tracks changes over time.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any point without it affecting your ongoing medical care.

How to find out more

Jeane Guevara

MIBREAST@rmh.nhs.uk +44 20 3186 5420 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.