[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603456":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Royal Marsden NHS Foundation Trust","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Standard of Care",null,"2D catalogue of photographs of other patients who have had surgery to demonstrate the predicted post-operative appearance",{"label":13,"type":10,"description":14,"interventionNames":10},"3D Surface Imaging","3D Simulation of patients own breast to show them how they might look after surgery",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Jeane Guevara","CONTACT","+44 20 3186 5420","MIBREAST@rmh.nhs.uk",[22],{"facility":5,"status":23,"city":24,"state":10,"zip":10,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"RECRUITING","London","United Kingdom","UK",{"type":28,"coordinates":29},"Point",[30,31],-0.12574,51.50853,{"lat":31,"lon":30},[34,37,40],{"name":35,"role":18,"phone":10,"phoneExt":10,"email":36},"Astrid Leusink","Astrid.Leusink@icr.ac.uk",{"name":38,"role":39,"phone":10,"phoneExt":10,"email":10},"Jennifer Rusby","PRINCIPAL_INVESTIGATOR",{"name":35,"role":41,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100603456","mibreast-making-in-immediate-breast-reconstruction-and-the-measurement-of-the-effects-of-radiotherapy-100603456",false,"NCT07136753","MIBREAST Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy","The IMpact of 3D Surface Imaging and Simulation on Shared Decision Making in Immediate Breast REconstruction And the Measurement of the EffectS of RadioTherapy","MIBREAST","Inclusion Criteria:\n\n* Female\n* Aged \\> 18\n* Undergoing immediate breast reconstruction (autologous or implant based) follow mastectomy for breast cancer or as a risk-reducing strategy\n* Available to attend 3D-SI appointments at specified intervals\n\nExclusion Criteria:\n\n* Lack of capacity\n* Language barrier that prevents patients from understanding the English questionnaires\n* Visual impairment\n* Unable to answer study questionnaires\n* Disability that may prevent appropriate positioning during the imaging process\n* Unable to attend for photography\n* Requiring delayed reconstruction or no longer considering a reconstruction","FEMALE","18 Years",{"count":55,"type":56},300,"ESTIMATED","OBSERVATIONAL","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.\n\nPatients 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.\n\nThis study will investigate the following 3 questions:\n\n1. Whether 3D-SI and simulation can improve patient confidence about their likely post-surgery appearance\n2. 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\n3. 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.\n\n3D 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:\n\n1. 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\n2. 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.",[60],"Breast Cancer",[62,63,64],"Decision making","Reconstruction","Risk reducing surgery","2025-08-14",{"date":67,"type":68},"2025-08-22","ACTUAL",{"date":70,"type":68},"2024-09-12",{"date":72,"type":56},"2030-09",{"name":5,"class":6},1]