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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Lack of capacity

Language barrier that prevents patients from understanding the English questionnaires

Visual impairment

Unable to answer study questionnaires

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Standard of Care
Group B: 3D Surface Imaging

Trial outcomes

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)

Time frame
Preioperative/Periprocedural

Secondary outcomes

1

Difference in decisional conflict scale score

Difference in Decisional Conflict Scale (DCS) score for women who see and do not see their simulated reconstruction

Time frame
Perioperative/Periprocedural
2

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

Time frame
Perioperative/Periprocedural
3

Thematic analysis of surgeons' experience

Thematic analysis of surgeons' experience

Time frame
1 year
4

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

Evaluation of the actual outcome against the simulated appearance

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.