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 nodules/masses, transbronchial needle aspiration biopsy of peripheral lung nodules/masses, transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes, and transbronchial cryo biopsy of peripheral lung nodules/masses. 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 technology's performance in detecting cancerous changes.

This research aims to evaluate the effect of adding docetaxel chemotherapy after radical radiotherapy in patients with localized high-grade prostate cancer. Participants must have prostate cancer confirmed by biopsy or surgery with a Gleason score of 9-10 or containing Gleason 5 components, and no signs of distant spread. The goal is to understand if this additional chemotherapy improves survival outcomes compared to standard treatment alone. Participants will be divided into two groups. One group will receive standard radical treatment, including radiotherapy or surgery, and may also receive endocrine therapy as recommended. The other group will receive the same standard treatment followed by four to six cycles of intravenous docetaxel chemotherapy starting 4 to 8 weeks after radiotherapy. In some cases with significant neuroendocrine features, docetaxel combined with carboplatin may be given. Dexamethasone will be used before chemotherapy to reduce side effects. During the study, participants will be monitored for failure-free survival over five years, along with secondary measures such as biochemical relapse-free survival, metastasis-free survival, overall survival, and treatment-related toxicities. Regular assessments including imaging and blood tests will be conducted to check for cancer progression and safety. The trial is planned to continue until 2031, allowing long-term follow-up of outcomes and side effects.

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 system's 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 model's 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 model's 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 studying breast cancer patients who have positive sentinel lymph nodes after receiving neoadjuvant systemic treatment. The trial aims to compare two approaches: axillary radiotherapy (ART) without lymph node removal and axillary lymph node dissection (ALND) with radiotherapy. This study evaluates whether ART can reduce the risk of lymphedema without worsening cancer outcomes, including recurrences and overall survival, while also assessing quality of life. Participants will be randomly assigned to one of two groups: one receiving axillary radiotherapy targeting levels I and II and additional areas without lymphadenectomy, and the other undergoing axillary lymph node dissection combined with radiotherapy to other lymph node regions. The study plans to enroll 820 patients over five years, including those treated with chemotherapy or hormone therapy as neoadjuvant treatments. An initial pilot phase involved 200 patients, and an interim analysis will be conducted. Throughout the study, participants will be monitored for disease-free survival up to five years, noting the time until cancer recurrence or death. Researchers will also track overall survival over five years and the incidence of lymphedema for up to three years post-surgery. Quality of life and treatment side effects will be evaluated. Patients will undergo imaging with ultrasound or MRI to assess axillary response, and their treatment completion will be recorded. This comprehensive follow-up ensures careful evaluation of safety and efficacy over time.

Researchers are collecting various biological samples, such as blood, urine, body fluids, skin swabs, and skin biopsies, to support medical research conducted by the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. The samples help study infectious diseases like HIV and hepatitis, immune system responses, and the development of vaccines and monoclonal antibodies. The study includes children from 3 years old and adults, including healthy volunteers and those with infections or allergic or autoimmune conditions. Specimens are collected through standard blood draws (phlebotomy) or apheresis, which involves removing blood, separating desired components like plasma or white blood cells, and returning the rest to the participant. The apheresis procedure takes about 1 to 3 hours with the participant reclining. Samples may also include mucosal secretions, skin swabs, and biopsies. Collection can occur at clinic visits, outside labs, or at home, with shipments sent to the research center. Participants may donate samples once or repeatedly over a 1-year enrollment period, which can be extended. Participants undergo sample collection and provide basic medical and demographic information linked to their samples by ID number only. The study monitors safety during procedures and collects data on participant identity proof and consent. There are no specific study endpoints as samples support various research projects. Participation can last a year or more, with ongoing review by an ethics committee. The primary outcome measured is the successful collection of samples for research use.

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 technology's 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 system's 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.