Fluorescence Imaging

Researchers are conducting a pilot study to evaluate a new portable 0.7 Tesla T MRI brain scanner developed at the Center for Magnetic Resonance Research CMRR. This study aims to demonstrate the human brain imaging capabilities of this innovative device, which is designed to be compact and more accessible compared to traditional MRI machines. The study uses a unique high-temperature superconducting magnet-based scanner that is lightweight, weighing only 400 kg, and requires no cryogens. The device allows participants to sit normally with clear sightlines to the room and produces lower noise during scanning, enhancing comfort during the procedure. Participants will undergo brain imaging using the portable 0.7 T MRI scanner. Researchers will assess the quality of the images obtained on the first day of scanning as the primary outcome. The study includes healthy volunteers aged 18 and older who can consent for themselves and have no contraindications for MRI. The total duration and follow-up details are not specified.

This trial evaluates a single-arm, blinded histopathology study of AS1986NS, a fluorescent agent, in men suspected of having prostate cancer. The study focuses on prostate cancer adenocarcinoma and uses fluorescence imaging to assess the diagnostic potential of AS1986NS. The research is sponsored by Antelope Surgical Solutions, Inc and is conducted as a phase 1 and 2 interventional trial. Participants receive one single intravenous injection of 100 micrograms of AS1986NS through peripheral intravenous access. The study does not include a comparison group and is designed to monitor the safety of this single dose. The primary purpose is diagnostic, so the trial focuses on the performance of AS1986NS in imaging and histopathology. During the study, participants are observed from enrollment until 30 days after the infusion to monitor safety outcomes. The main measure is the safety of AS1986NS during this period. Participants will undergo standard prostate biopsy as part of routine care, with additional imaging and assessments related to the study treatment. The total participation lasts around one month post-infusion.

This research aims to evaluate Bevonescein, a sterile intravenous drug, in patients undergoing minimally invasive abdominopelvic surgery. The study focuses on assessing the safety, tolerability, and effectiveness of Bevonescein in highlighting nerves and ureters during surgery. It also investigates how the drug behaves in the body and the dose needed to produce clear fluorescent imaging for nerve and ureter visualization. Participants will receive Bevonescein during two study phases a dose defining phase and a dose expansion phase for each surgical setting. The drug is given as an intravenous infusion, and the study uses specialized imaging systems to record fluorescence signals in targeted tissues. These phases help determine the optimal dose and gather safety and imaging data. Throughout the study, participants will be monitored with fluorescence system surveys approximately 28 days after dosing, plus or minus 5 days. Researchers will collect data on the drugs imaging effects and safety. The total duration includes screening, dosing, and follow-up assessments to evaluate Bevonesceins performance during minimally invasive surgery.

Researchers are evaluating the accuracy and feasibility of an AI-assisted blind-sweep obstetric ultrasound called SPAQ E-con AI, used by trained non-specialist health workers for antenatal screening in rural Democratic Republic of the Congo. This multi-center prospective study includes about 1,430 pregnant women and aims to compare AI measurements of gestational age and fetal conditions to manual measurements by expert readers. The study also includes an adaptive model update plan following regulatory guidance. Participants undergo ultrasound scans using a smartphone-based 9-sweep technique operated by trained non-specialists after short training. The AI estimates gestational age, fetal presentation, and placenta location. The study includes natural enrollment of antenatal care attendees and enriched groups for placenta praevia, fetal malpresentation, and early pregnancy cases. Data collection spans up to 12 months, with interim analyses and adaptive updates planned. During the study, participants receive routine antenatal care while undergoing ultrasound screening. Researchers measure gestational age accuracy in second and third trimesters, AI confidence calibration, and secondary outcomes like sensitivity for placenta praevia, inter-rater reliability, and acceptability of the intervention. They also track protocol adherence, screening coverage, and sustainability of AI use. The study lasts through completion up to June 2027, with ongoing data collection and monitoring.

Researchers are evaluating how the timing of artificial intelligence AI support affects chest X-ray interpretation by healthcare professionals. This study explores whether showing AI information before or after a clinician first reviews a chest X-ray changes their visual search behavior, interpretation time, decision-making, confidence, and trust in AI. The study uses a behavioral diagnostic reader design involving eye-tracking technology to better understand these effects in a controlled NHS research setting. Participants will complete two chest X-ray interpretation sessions spaced at least four weeks apart, using the same set of de-identified images. In one session, AI output is shown before the clinician reviews the X-ray, while in the other session, the AI information is shown after the initial review. Each session involves a two-phase interpretation process where either the X-ray or AI output is first viewed, followed by the introduction of the other source before final interpretation submission. Eye-tracking equipment records visual attention and search patterns during the tasks. Participants will review 25 chest X-ray cases per session and complete questionnaires about their experience with AI support. Researchers will analyze interpretation time, diagnostic accuracy, clinical recommendations, confidence, trust, and visual search behavior. Data collected includes eye-tracking metrics, structured interpretation responses, and participant feedback. The study does not involve patients directly, change clinical care, or use AI for actual diagnosis. It aims to provide evidence to guide safer and more effective use of AI in chest X-ray interpretation.

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 the safety and feasibility of early post-operative brain PET-MRI imaging in adults who have undergone surgery for suspected glioblastoma. The study aims to validate specific nuclear imaging parameters to improve detection of residual tumor tissue compared to standard gadolinium-enhanced MRI. This prospective interventional diagnostic study will include 15 patients at a single site in France, focusing on imaging within 48 hours after surgery and monitoring for side effects related to the imaging procedures. Participants will undergo combined PET-MRI imaging using 18F-DOPA as the radiotracer and gadolinium-based contrast for MRI enhancement. The PET scan involves an intravenous injection of 18F-DOPA at 2 MBqkg with static brain acquisition starting immediately after injection. MRI sequences include diffusion, spectroscopy, perfusion, and angiography scans. Patients will be monitored for radiation exposure and any adverse events during and after imaging, with a total monitoring period of 24 hours post-procedure. During the study, participants receive a pre-surgical baseline evaluation including medical history, PET-MRI, and MRI scans within 30 days to 2 days before surgery. After surgery, informed consent is obtained, followed by post-operative PET-MRI imaging and monitoring in the nuclear medicine department. Dosimetry measurements occur over 24 hours to assess radiation exposure. Safety assessments include observation for hypersensitivity or side effects related to gadolinium or 18F-DOPA. The study lasts approximately 24 hours per patient, with follow-up managed by the usual neurosurgical care team.

Diabetes is a widespread chronic condition that leads to high risks of cardiovascular problems and lower limb amputations. This research explores how Spatial Frequency Domain Imaging SFDI, a noninvasive optical method, can assess blood flow changes before and after lower limb revascularization procedures like angioplasty in diabetic patients. The trial aims to determine if SFDI can provide objective feedback to predict outcomes and aid early intervention to save limbs. Participants will undergo SFDI imaging on both the treated and untreated feet, focusing on the heel and pad areas. Imaging is done before and after the angioplasty procedure on the same day to capture changes in tissue oxygen saturation and hemoglobin. This pilot study involves 15 diabetic patients having lower limb arterial angioplasty. During the study, participants will have noninvasive foot assessments using SFDI to monitor tissue oxygen levels and blood flow. Researchers will compare these imaging results with toe pressure measurements to evaluate changes in perfusion caused by angioplasty. The primary measure is the change in tissue oxygen saturation immediately before and after the procedure. The overall participation lasts around the intervention day with imaging assessments pre- and post-operation.

Researchers are evaluating the safety and effectiveness of using preoperative aerosol inhalation of Indocyanine Green ICG solution to improve thoracoscopic surgery for congenital lung malformations in children. This study focuses on children aged between 3 months and 14 years who have been diagnosed with congenital lung malformations, aiming to help surgeons accurately identify and remove affected lung tissue. Before surgery, children undergo pulmonary ventilation function evaluation and enhanced lung CT scans. Approximately 30 minutes before surgery, they inhale an ICG solution dissolved in saline at a dose of 0.5 mgkg. During surgery, a fluorescence thoracoscope is used to clearly differentiate normal lung tissue from diseased tissue by fluorescence staining. The lesion boundaries are marked, and lung tissue is carefully dissected using specialized surgical tools. After removing the lesion, the surgical area is examined for bleeding or air leaks, followed by chest drainage tube placement. Participants are followed up 3 to 6 months after surgery with outpatient visits including pulmonary CT scans and lung function tests. Measurements such as tidal volume, inhalationexhalation time ratio, peak time ratio, and peak volume ratio are compared before and after surgery. Researchers also monitor the rate of residual disease at 3 months and hospital stay length up to 14 days to assess outcomes and safety.

Researchers are conducting a study to compare bone mineral density BMD measurements from two types of low-dose X-ray exams EOSedge and traditional DXA. The study aims to determine if the T-scores calculated from these two imaging methods agree. This multi-center, prospective, controlled, cross-sectional agreement study involves participants who either need EOSedge imaging as part of their routine care or volunteers undergoing non-diagnostic imaging. Participants will undergo both EOSedge and DXA scans. EOSedge exams will be performed as usual for evaluating spinal or orthopedic conditions, while DXA exams will be done as study-prescribed or standard care, ideally on the same day as EOSedge but up to 60 days apart. Healthy volunteers will receive both imaging tests, and those receiving EOSedge imaging as standard care will also receive an additional DXA scan. During the study, participants will have demographic and diagnostic information collected via case report forms and complete a questionnaire before the DXA scan. The researchers will assess the agreement of T-scores between the two imaging methods over a period of up to 60 days. The total duration of participation covers consent through completion of image acquisition. Safety is monitored by excluding participants with conditions affecting imaging quality or safety risks.