[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mastectomy-and-breast-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mastectomy-and-breast-reconstruction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,72,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100626362","comparison-of-mastectomy-expander-trial-100626362",false,"NCT07434648","Comparison of Mastectomy Expander Trial","Comparison of Clinical Outcomes and Molecular Mechanisms After Tissue Expander Implantation in Mastectomy Patients - a Single Center, Randomized Controlled, Exploratory Clinical Trial","COMMET","Inclusion Criteria:\n\n* Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n* Female subjects aged ≥ 18 years at time of consent\n* INDICATION: Breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy OR ductal carcinoma in situ (DCIS) diagnosis without neoadjuvant chemotherapy AND \u002F OR positive genetic counseling for high-risk family history of breast cancer\n* RECONSTRUCTION MODALITIES: planned uni- or bilateral NSME or SSME with simultaneous prepectoral tissue expander-based breast reconstruction due to malignancy OR Planned prophylactic bilateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction. Planned unilateral NSME or SSME and planned prophylactic contralateral mastectomy with simultaneous prepectoral tissue expander-based breast reconstruction\n* Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said or written.\n* Inclusion criterion 6 only applies to subject with radiotherapy: Adjuvant radiotherapy as part of the breast cancer treatment plan\n* Inclusion criterion 7 only applies to women of childbearing potential (WOCBP): negative urine pregnancy test, not breastfeeding\n\nExclusion Criteria:\n\n* Subject with implanted device that may be affected by magnetic fields (pacemaker)\n* Known presence of HIV, viral hepatitis (patient-reported)\n* Presence of autoimmune disease(s) or immunocompromised subject due to immunosuppressive or steroid therapy\n* The subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this study.","FEMALE","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the \"approved\" duration of 6 months (maximal 10 months). Additionally, some participants will receive after mastectomy\u002Fexpander implantation an adjuvant radiotherapy according to standard of care, which is either a contraindication of the medical device or not yet tested in-vivo by the manufacturer.\n\nRequested answers:\n\n* how good is the aesthetic outcome of the breast with the expanders and the final implants, and whether any complications occurred during treatment,\n* how satisfied are subjects and doctors with the outcome of the breast reconstruction, and how the reconstruction affects health-related quality of life from participants,\n* how does the structural composition of the removed expanders looks like, in order to understand whether radiation therapy has caused changes in the material,\n* which key immunological factors lead to increased hardening of the tissue around the expander, especially during radiation therapy (capsule formation).",[27,28,29,30],"Mastectomy and Breast Reconstruction","Tissue Expander Based Breast Reconstruction","Adjuvant Radiotherapy","Long Term Outcome",[32,33,34],"breast reconstruction","implant capsular fibrosis","tissue expander comparison","NOT_YET_RECRUITING","2026-02-20",{"date":38,"type":39},"2026-02-25","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2031-12-31",{"name":45,"class":46},"Medical University Innsbruck","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100610967","sexual-well-being-of-women-undergoing-mastectomy-and-reconstruction-100610967","NCT07234461","Sexual Well-being of Women Undergoing Mastectomy and Reconstruction","Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.","Inclusion Criteria:\n\n* Patients undergoing mastectomy for primary breast cancer;\n* High-risk healthy patients undergoing risk reducing mastectomies;\n* Unilateral and\u002For bilateral mastectomies;\n* If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;\n* All reconstructive procedures included (autologous and heterologous reconstructions).\n\nExclusion Criteria:\n\n* Patients undergoing breast conservation;\n* Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;\n* Delayed post-mastectomy reconstructions;\n* Patients not available for e-correspondence.",true,{"count":56,"type":21},200,[24],"The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys.\n\nThis data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments.\n\nSpecific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy).\n\nOur goal is to improve quality of life of breast cancer patients.",[27,60],"Sexual Wellness","RECRUITING","2026-02-02",{"date":64,"type":39},"2026-02-04",{"date":66,"type":39},"2026-01-21",{"date":68,"type":21},"2026-10",{"name":70,"class":46},"European Institute of Oncology",19,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100616643","longitudinal-evaluation-of-direct-neurotization-technique-in-breast-reconstruction-with-fully-autologous-components-100616643","NCT07308275","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.\n* Patients undergoing breast reconstruction.\n* Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and\u002For chemotherapy or receiving no adjuvant therapy).\n* Willing to comply with all scheduled examinations and tissue sampling procedures.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications).\n* Bilateral mastectomy.\n* Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.\n* Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).\n* Refusal or inability to attend follow-up evaluations.",{"count":80,"type":21},28,[24],"This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.\n\nThe study's primary questions are:\n\n1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations?\n2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module?\n\nAs secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:\n\n1. Neuregulin-1 (NRG1) expression in flap tissue biopsy;\n2. Cross-sectional area of the recipient nerve fibres;\n3. Breast morphometry measured at baseline and follow-up;\n4. Intraepidermal nerve fibre density (IENFD) on skin biopsy.\n\nParticipants will be randomly assigned to receive either:\n\n1. Neurotized autologous breast reconstruction using fully autologous graft components, or\n2. Standard (non-neurotized) autologous breast reconstruction.\n\nThe study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery.\n\nParticipants will undergo:\n\n1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery.\n2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months.\n3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit.\n\n3\\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool.\n\nThis study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.",[84,85,27,86,87,88],"Breast Reconstruction After Mastectomy","Neurotization","Peripheral Nerve Regeneration","Sensory Function","Quality of Life (QOL)",[90,91,92,93],"breast neurotization","mastectomy","breast sensory","quality of life","2025-12-15",{"date":96,"type":39},"2025-12-29",{"date":94,"type":21},{"date":99,"type":21},"2027-04-15",{"name":101,"class":46},"Fakultas Kedokteran Universitas Indonesia",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100589594","prediction-of-icg-for-skin-necrosis-in-mastectomy-with-immediate-reconstruction-100589594","NCT06956443","Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction","The Predictive Value of Quantified Indocyanine Green Fluorescent Angiography for Skin Necrosis in Mastectomy With Immediate Reconstruction","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patients undergoing mastectomy with immediate reconstruction using ICG-NIR\n3. Patients are mentally competent\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with known allergy to ICG or iodinated contrast media\n2. Pregnant or lactating women\n3. Patients with dialysis-dependent renal failure and renal transplantation",{"count":111,"type":21},50,"OBSERVATIONAL","Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.\n\nWhen assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.\n\nICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.\n\nWhat is the purpose of the study\u002Fresearch question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.\n\nStudy design\u002Fprocedure and intervention:\n\nThis will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).\n\nThis study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin\u002Ffat necrosis).\n\nAll patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.",[115,27,116],"Breast Cancers","Skin Necrosis",[118,91,119,32,120],"ICG","breast cancer","skin necrosis","2025-04-25",{"date":123,"type":39},"2025-05-04",{"date":125,"type":21},"2025-06-01",{"date":127,"type":21},"2026-12-01",{"name":129,"class":46},"University Medical Center Groningen"]