Breast Implant Complication

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive (ER+) breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI scans. The study focuses on comparing these two diagnostic tracers' accuracy in detecting cancer lesions in ER+ breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.

Researchers are evaluating a new approach to eliminate minimal residual disease (MRD) in patients with triple negative breast cancer (TNBC) that remains after multiple treatments. This aggressive cancer type often leads to lethal metastatic disease within 2 years, especially in patients without a complete tumor response after initial chemotherapy. The study aims to improve survival and cure rates by addressing residual cancer cells despite surgery and chemotherapy. The study has two phases. Phase I involves patients with metastatic TNBC or hormone-resistant, HER2/neu-negative breast cancer receiving escalating doses of sarilumab combined with capecitabine chemotherapy. Sarilumab is given subcutaneously every 3 weeks alongside capecitabine taken twice daily for 14 days in 21-day cycles. Phase II includes patients with stage I to III TNBC with residual disease after neoadjuvant therapy, treated with a combination of sarilumab and capecitabine compared to historical controls receiving capecitabine alone. A parallel baseline arm receives standard capecitabine alone. Blood samples and optional bone marrow samples are collected during treatment. Participants will be monitored through blood tests and other evaluations during treatment cycles lasting up to 14 weeks. Researchers will assess the maximum tolerated dose and dose-limiting toxicities in Phase I and measure changes in circulating and disseminated tumor cells in Phase II. The study does not include masking or randomization. Participants must meet specific health and organ function criteria and agree to contraception requirements if applicable. The total study duration varies by participant, with safety and response closely observed throughout.

Researchers are evaluating whether the Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections following implant-based breast reconstruction in women aged 18 and older. The study also aims to compare the safety and overall surgical outcomes between Xperience™ and povidone-iodine. This clinical trial is a randomized controlled trial sponsored by the University of North Carolina, Chapel Hill. Participants will be randomly assigned to receive either the Xperience™ solution or the dilute povidone-iodine solution during their bilateral implant-based breast reconstruction surgery. Xperience™ will be applied twice during the procedure, soaking both the mastectomy pockets and implants with specific volumes and dwell times before insertion. The povidone-iodine solution will be applied similarly. Surgical site closure will follow standard procedures for all participants. During the study, participants will have regular post-operative check-ups to monitor for infections and other complications. Researchers will collect data on the rates of surgical site infections, premature implant removal due to infection, and non-infectious post-surgical complications within 90 days after implant placement. The study will monitor safety and overall outcomes through these evaluations, with participation lasting through this 90-day post-surgery period.

Researchers are collecting detailed information in a registry to better understand various types of mature T-cell and natural killer (NK)-cell lymphomas. This observational study aims to improve knowledge about these rare blood cancers by creating a comprehensive database that includes clinical information and tumor samples from participants. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on multiple specific T-cell lymphoma subtypes as defined by recognized classification guidelines. Participants with confirmed mature T-cell or NK-cell lymphoma may choose to provide optional blood and nail samples for future research and biobanking. The study does not involve experimental treatments but gathers data prospectively from individuals meeting strict diagnostic criteria, including those receiving systemic therapy for certain cutaneous lymphoma types. This approach supports long-term data collection rather than testing new therapies. During the study, participants will have clinical data and tumor specimens collected and recorded. Researchers will track the number of participants contributing to the T-cell Lymphoma Master Repository over a 10-year period. The study involves ongoing follow-up to measure disease status and treatment response, with no direct intervention required. Participation helps build a resource to advance future research and understanding of these lymphomas.

Researchers are examining why people have different risks and outcomes for breast cancer and related breast diseases. This observational study focuses on a diverse population in South Florida, aiming to better understand both genomic and non-genomic factors that affect breast cancer risk and outcomes. The study is led by Memorial Sloan Kettering Cancer Center and includes men and women aged 18 years and older who visit breast radiology clinics for biopsy or as new breast patients. Participants will undergo blood collection at the start and during surgery when applicable, as well as tissue collection during surgery if possible. They will also complete surveys at baseline, after surgery, and at 1, 3, and 5 years of follow-up. The study involves participants with BIRADS scores from 0 to 5 and follows their clinical characteristics over up to five years. Throughout the study, participants will provide clinical information through surveys and biological samples to help researchers track their health outcomes. The main outcome measured is the clinical characteristics of participants obtained via surveys over five years. The study provides long-term monitoring of participants' breast health, with no intervention treatments involved, and aims to collect comprehensive data to understand breast cancer risks better.

Researchers are studying the effects of local treatment on health and daily life in people with early-stage breast cancer in China. The focus is on those with stage I to III invasive breast cancer receiving surgery and other therapies before or after surgery. The study aims to understand both short- and long-term physical, emotional, and social effects of treatment, including tiredness, sleep problems, emotional distress, pain, and changes in heart or lung function, to improve recovery and quality of life. Participants will receive local therapy with curative intent, which may include surgery, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given before or after surgery. This observational study involves no experimental treatment. At the start, participants undergo clinical assessments, including heart and lung tests, lab work, and collection of blood and tissue samples. They also complete questionnaires about symptoms and well-being at multiple time points over five years. During the study, participants will complete surveys about their physical symptoms, emotional health, and quality of life at baseline, one week, one month, three months, six months, one year, and then annually up to five years. Researchers will monitor treatment-related toxicities and quality of life changes through these patient-reported outcomes. The study uses electronic data collection with quality checks to ensure accurate and consistent information for analysis and future research.

This research aims to observe the safety and performance of Silimed4 silicone gel breast implants with two different surfaces: textured and polyurethane coated. The study focuses on female patients who have undergone either primary or secondary breast augmentation using these implants and follows them for a period of 10 years. The purpose is to assess both known and unexpected short- and long-term risks or adverse events related to each type of implant, as well as to evaluate patient satisfaction and quality of life after implantation. The study involves two groups of women: those who received Silimed4 Textured Silicone Gel-Filled Breast Implants and those who received Silimed4 Polyurethane Foam Covered Silicone Gel-Filled Breast Implants. Participants are followed up every three years over the 10-year duration to monitor safety and performance outcomes. Both types of implants are being studied as devices, and the research tracks how each implant surface affects patient experiences and outcomes. Participants will have regular assessments every three years throughout the study to document expected and unexpected adverse events, satisfaction with aesthetic results and general satisfaction, evaluator satisfaction, and quality of life. These evaluations help researchers understand the long-term effects of the implants and how they impact patients' well-being. The total follow-up period spans 10 years, providing a comprehensive view of implant safety and patient satisfaction over time.

Researchers are evaluating the safety and performance of Silimed4 brand smooth surface breast implants in women who need primary or secondary (revision) breast augmentation. The study aims to monitor known and unexpected adverse events and assess patient satisfaction and quality of life following implantation. This observational study will follow participants for 10 years to gather long-term information about the implant's effects. Women in the study will receive Silimed4 smooth surface breast implants either for initial breast augmentation or for revision surgery. There are two groups: one for primary augmentations and another for secondary or revision augmentations. The study does not involve any experimental treatments but observes outcomes after these implants are placed. Participants will be followed up every three years over the 10-year study period. During these visits, researchers will collect data on expected and unexpected adverse events, patient satisfaction with aesthetic results and overall experience, evaluator satisfaction, and quality of life. The study will also monitor safety by recording any adverse events reported by patients throughout the follow-up period.

This trial studies patients who have undergone mandibular bone grafts from the iliac crest, a common source of bone for dental implants. Researchers are evaluating whether using a bone-condensing technique called osseodensification with densah burs can improve the stability of dental implants and reduce bone loss around the implant compared to conventional bone drilling. The study is randomized and double-blinded to compare these two drilling approaches. Participants will be divided into two groups: one group will have dental implants placed using the osseodensification technique with densah burs, and the other group will have implants placed with standard bone drills. This study focuses on implants placed in consolidated mandibular bone grafts following segmental mandibular resection. The observation period for implant stability and bone loss is six months after implant placement. Participants will be evaluated over a six-month osseointegration period during which radiographic images will be taken to measure bone loss around the implants. Implant stability will also be assessed during this time. The study will monitor the bone and implant condition closely, aiming to understand the differences between the two drilling techniques in supporting implant success. The total age range for participants is 18 to 55 years, and healthy soft tissue coverage around the implant site is required.