Biopsy

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit LIVA at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

This research aims to evaluate deep learning algorithms designed to detect suspicious cell and tissue patterns for cancer in biopsies taken from peripheral lung nodules, masses, and mediastinal or hilar lymph nodes. The study uses the NIO Laser Imaging System during bronchoscopy procedures to image samples without traditional processing. It is a prospective, observational study focusing on rapid lung cancer detection with artificial intelligence assistance. The study includes four groups based on biopsy location and method transbronchial forceps biopsy of peripheral lung nodulesmasses, transbronchial needle aspiration biopsy of peripheral lung nodulesmasses, transbronchial needle aspiration biopsy of mediastinalhilar lymph nodes, and transbronchial cryo biopsy of peripheral lung nodulesmasses. Each biopsy procedure is performed as part of routine clinical care, and imaging is done in the procedure room using the NIO Laser Imaging System. Participants are adults scheduled for clinically indicated lung biopsies with an intermediate to high likelihood of lung cancer. The study tracks outcomes from enrollment until the end of each biopsy procedure. Researchers will assess how well the deep learning algorithms identify suspicious morphology during the procedure. Participants will be monitored during their procedures, and data will be collected to validate the technologys performance in detecting cancerous changes.

Researchers are studying the effects of adding docetaxel chemotherapy after standard radical treatment in men with localized high-grade prostate cancer, specifically those with a Gleason score of 9-10 or containing a Gleason 5 component, without distant metastasis. The goal is to understand if this additional chemotherapy improves survival outcomes compared to standard treatment alone. The study includes men aged 18 to 80 with good performance status and adequate blood counts. Participants will be divided into two groups one receiving only standard radical treatment such as radiotherapy or surgery, possibly combined with endocrine therapy according to guidelines, and the other receiving the same standard treatment followed by four to six cycles of docetaxel chemotherapy given intravenously every 21 days starting 4 to 8 weeks after radiotherapy. In some cases with certain tumor features, docetaxel may be combined with carboplatin. Dexamethasone is given before chemotherapy to help reduce side effects. During the trial, participants will be monitored over five years to assess failure-free survival as the primary outcome, along with biochemical relapse-free survival, metastasis-free survival, overall survival, and treatment toxicities. Researchers will collect data through regular follow-ups to evaluate how well patients do after treatment and to track any adverse events. The study aims to provide clearer information about the benefits and risks of adding chemotherapy after radical treatment in this group of prostate cancer patients.

Researchers are evaluating the feasibility and safety of an artificial intelligence AI-driven autonomous registration technology in robotic navigational bronchoscopy for patients with pulmonary nodules needing localization. The study will enroll 20 patients to assess how well this AI system aligns pre-operative chest CT images with real-time bronchoscopic anatomy, aiming to reduce the need for manual registration by physicians. The main goals include measuring the success of the AI registration and how often manual help is needed during the process. All participants will undergo robotic navigational bronchoscopy and nodule localization using the Langhe Bronchoscopy Robot System equipped with the AI-based autonomous registration software. Physicians will oversee the procedure and intervene manually if the AI registration does not meet safety or quality standards. This approach focuses on improving the registration process before the bronchoscopic procedure begins. Participants will be closely monitored during and after the procedure with assessments of registration success, time used for registration, any complications within 24 hours, and success in localizing nodules. The study involves collecting data during the operation and immediately afterward to evaluate the AI systems performance and safety. Total study participation includes the procedure and short-term follow-up to check for complications and outcomes.

Researchers are evaluating a new noninvasive system that uses artificial intelligence AI to analyze multiple types of imaging, including magnetic resonance enterography MRE and computed tomography enterography CTE, to help diagnose and predict outcomes for digestive diseases. This observational study collects and analyzes retrospective imaging, endoscopic, and clinical data from 21 centers in China to build and improve the AI model. The model will then be tested prospectively in two centers and its ability to locate lesions will be checked in real-world endoscopy settings. The study involves using a virtual endoscopy model to assist in diagnosis by integrating and analyzing multimodal imaging features. The AI system is designed to support diagnosis without any invasive procedures. The study will confirm the models accuracy and effectiveness through retrospective data, prospective validation, and real-world deployment in clinical environments. Participants will contribute data from their imaging and endoscopic exams, with at least one technically adequate CT or MR scan and a high-quality colonoscopy performed within one month of imaging. Researchers will assess the AI models diagnostic performance by measuring the area under the ROC curve AUC over six months. The study includes ongoing monitoring of data quality and imaging accuracy to ensure reliable validation of the AI system.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

This research aims to collect various human biological samples such as blood, urine, body fluids, skin swabs, and skin biopsies to support medical studies conducted by the National Institute of Allergy and Infectious Diseases Vaccine Research Center. These samples help researchers study diseases including HIV and hepatitis, understand immune responses to infections or vaccinations, and assist in vaccine development. The study is observational and involves volunteers aged 3 years and older. Participants may provide samples through standard blood draws or apheresis, a process that collects larger amounts of blood components by separating them and returning the rest to the body. The apheresis procedure lasts about 1 to 3 hours and is performed with participants resting on a recliner. Depending on the specific research needs, volunteers may donate samples once or multiple times during their enrollment, which lasts for one year and can be extended. Throughout the study, participants will provide specimens that are stored and used for various laboratory research projects related to immunity and vaccine development. Personal information linked to the samples is limited to a participant ID to maintain privacy. The study does not have specific endpoints but focuses on collecting samples safely and according to good clinical practices. Participants may be asked to provide proof of identity and complete informed consent, and their health status will be assessed to ensure safe participation.

Breast cancer is a growing health concern, particularly in China where its incidence has rapidly increased. This research focuses on patients undergoing breast-conserving surgery combined with sentinel lymph node biopsy to evaluate a new intraoperative cellular detection technology called the EndoScell Scanner ES. The study aims to assess how well the ES technology can detect sentinel lymph node status during surgery compared to traditional methods, helping guide treatment decisions more quickly and accurately. The study uses the EndoScell Scanner, which employs a miniaturized fluorescence microscope system to capture ultra-high-resolution images at the cellular level during surgery. This device uses fluorescent dyes, including a new dye, mitoxantrone, for sentinel lymph node tracing to avoid interference effects. Alongside the ES technology, imprint cytology is also performed intraoperatively. Surgeons will primarily rely on imprint cytology results during surgery, while the ES technologys accuracy and image quality are assessed retrospectively. Participants will undergo sentinel lymph node biopsy with intraoperative evaluation using both the ES technology and imprint cytology. The study will measure the accuracy of ES in assessing lymph node status by comparing it to standard paraffin pathology results obtained about two weeks after surgery. Additional assessments include the quality of imaging, surgeon learning curves, detection time, and reoperation rates at three months. The total study duration for these outcomes is approximately one year, with continuous monitoring and data collection.

Researchers are evaluating the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy TBLC in people with progressive pulmonary fibrosis. The study aims to understand patient prognosis, health economic impacts, and how therapeutic strategies may change following TBLC. Participants diagnosed with progressive pulmonary fibrosis will be randomly divided into two groups to receive either transbronchial lung biopsy TBLB or TBLC. The study compares two procedures transbronchial cryobiopsy, a newer technique used to diagnose various diffuse lung diseases, and transbronchial lung biopsy, a more commonly used and relatively safe diagnostic method. These procedures will be performed to assess their diagnostic value and safety in this patient population. Participants are assigned randomly to one of these two biopsy methods. During the study, participants will be monitored for diagnostic performance one month after biopsy. Safety assessments will be conducted at seven days and one month after the procedure. Researchers will collect data on lung function, imaging, and clinical status to evaluate outcomes. The study will continue until the end of 2026, with detailed follow-up to measure the impact of each biopsy technique on diagnosis and patient care.

This research aims to evaluate an artificial intelligence AI system designed to automatically assess the extent of gastric intestinal metaplasia GIM during endoscopy by calculating the EGGIM scores. Gastric intestinal metaplasia is an important precancerous condition, and the study seeks to validate the accuracy, performance, and reliability of this AI-assisted scoring method in a prospective, multi-center setting. Participants will undergo an image-enhanced endoscopy IEE examination, where both experienced endoscopists and the AI system independently assess the extent of GIM using the EGGIM score. This study builds on prior preliminary research and aims to confirm the AI systems diagnostic performance compared to human experts. During the study, patients aged 40 to 75 years who consent to participate will have their endoscopic images evaluated by both the AI and the endoscopists. The main outcome measured is how well the AI system diagnoses the grade of intestinal metaplasia by calculating the EGGIM score within one year. This observational study involves no experimental treatments, focusing on diagnostic evaluation and data collection over the study period.