[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eric R. Henderson\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100622577","phase-1-study-of-lgw16-03-to-identify-nerves-100622577",false,"NCT07385430","Study of LGW16-03 To Identify Nerves","Phase 1 Study of LGW16-03 To Identify Nerves","Inclusion Criteria (All of the following criteria must be met by study participants to be eligible for study enrollment):\n\n1. Scheduled and medically cleared for a standard of care, open-field (not endoscopic) surgical procedure wherein a major nerve will be exposed and visible to the imaging equipment.\n2. Participants must be willing and able to provide informed consent for participation in the study and adhere to all study procedures.\n3. Intact motor and sensory function in the nerve to be imaged, as determined by physical exam performed by the operating surgeon or clinician on the study team, including:\n\n   1. 5\u002F5 motor strength in relevant muscle groups.\n   2. Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.\n   3. No documented history of neuropathy of any kind.\n4. Age ≥ 18 years old.\n5. Medical clearance for surgery provided by a supervising medical provider (surgeon or primary care provider).\n6. Adequate renal function defined as creatinine clearance ≥ 60mL\u002Fmin.\n7. Adequate liver function:\n\n   1. Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN in patients with Gilbert's disease)\n   2. ALT and AST ≤ 2.5 x ULN if no active liver involvement or ALT and AST ≤ 5 xULN with active liver involvement\n   3. Albumin ≥3 g\u002FdL\n8. Adequate hematologic and clotting function:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n   2. Platelet count ≥ 100 x 109\u002FL\n   3. Hemoglobin ≥ 8 g\u002FdL or ≥ 5.6 mmol\u002FL\n   4. International Normalized Ratio (INR) ≤ 1.5 x ULN\n9. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment\n10. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n11. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence.\n\nExclusion Criteria (Any of the following criteria would exclude a participant from study enrollment):\n\n1. Pregnant or breastfeeding persons who are not willing to stop breastfeeding. Due to the unknown safety profile of LGW16-03 in humans, and the potential for fetal or neonatal exposure through transplacental transfer or breast milk, breastfeeding is not allowed throughout the study and until at least 60 days after last dose.\n2. Nerve injury or dysfunction of any kind in the nerve to be imaged (e.g., diabetic neuropathy, multiple sclerosis, other neuropathy, traumatic nerve injury)\n3. Peripheral vascular disease requiring management a vascular surgeon.\n4. Prior surgery in the planned surgical region within the previous 365 days.\n5. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and\u002For heart failure within 1 year.\n6. Current evidence of renal or liver disease.\n7. History of fluorescein allergy.\n8. Direct administration of a local anesthetic agent in the region of the nerve to be imaged that could affect the motor or sensory function of the target nerve.\n9. Any other criteria deemed by the Principal Investigator that may prevent the participant from successfully completing the trial.","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03.\n\nParticipants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.",[26,27,28],"Adults","Open-field Surgery","Major Nerve",[30,31,32],"Surgery","Nerve","Fluorescence imaging","RECRUITING","2026-05-28",{"date":36,"type":37},"2026-06-01","ACTUAL",{"date":39,"type":20},"2026-06-15",{"date":41,"type":20},"2027-08-01",{"name":43,"class":44},"Eric R. Henderson","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100583551","real-time-diagnosis-of-life-threatening-necrotizing-soft-tissue-infections-nsti-using-indocyanine-green-icg-kinetic-modeling-100583551","NCT06877793","Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling","Inclusion Criteria:\n\n* Age ≥18 years.\n* Clinical suspicion of NSTI based on the local standard of care warranting:\n* Hospital admission for observation due to suspected NSTI; and\u002For\n* Soft tissue biopsy to rule in\u002Fout suspected NSTI; and\u002For\n* Surgical debridement for suspected NSTI; and\u002For\n* Specific institutional threshold criteria for triggering NSTI work-up; and\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* History of allergy to ICG and\u002For iodine.\n* Pregnant women or nursing mothers.",{"count":53,"type":20},420,"OBSERVATIONAL","Necrotizing soft-tissue infections (NSTIs, a.k.a. \"necrotizing fasciitis\" or \"flesh-eating bacteria\") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ failure, and death. NSTI cases present with non-specific clinical, imaging, and laboratory findings, and standard-of-care techniques for NSTI diagnosis lack sensitivity and specificity, resulting in frequent misdiagnosis and delayed care, which is the single most important predictor of survival. Consequently, the cumulative mortality rate for patients with NSTIs is 20- 30%; a dire need exists for more accurate and rapid detection of NSTIs. Fluorescence-guided surgery is a nascent technology seeking to improve the recognition of anatomical structures and disease processes using fluorescent probes (fluorophores). Indocyanine green (ICG) is an FDA-approved, near-infrared fluorophore with a \\>60-year safety record for vascular perfusion assessment. A distinguishing histological feature of NSTIs is prominent blood vessel thrombosis in affected tissues. Leveraging these pro-thrombotic effects, our study group has demonstrated in a first-in-human study (NCT04839302) that intravenous administration of ICG and immediate fluorescence imaging reveals prominent signal deficits in NSTI-positive tissues that differentiate significantly with increased signal seen with more common-and less virulent-infections such as cellulitis. We seek now to evaluate this imaging technique on a broader scale and determine if our findings are consistent for patients affected by NSTI-causing pathogens that are not endemic to our region. This prospective, observational, multicenter clinical study will involve video-rate ICG fluorescence imaging of patients suspected of having NSTIs who present to eight tertiary, Level 1 medical centers across the United States (Aim 1). Using dynamic contrast-enhanced fluorescence imaging (DCE-FI), time profiles of ICG fluorescence intensity from different tissue pixels\u002Fregions will be extracted and parameterized to extract first-pass kinetic features. These DCE-FI features, which characterize tissue perfusion, will be evaluated alone and in combination with anonymized electronic medical record data to create a DCE-FI-based clinical decision tool and a machine- learning-based fusion (DCE FI+lab\u002Fimaging data) tool; these will be compared to identify the most accurate means of diagnosing NSTIs (Aim 2). The best-performing tool will then be evaluated-compared to current diagnostic tests-in a prospective observational clinical study of patients presenting to tertiary emergency departments with findings concerning for NSTIs (Aim 3). Based on our human study, fluorescence imaging will not delay current standard of care. To ensure data fidelity, all sites will use similar: 1) commercial fluorescence imaging systems and accessories; and 2) validated commercial fluorescence reference phantoms. Based on our early results, we have strong confidence that following rigorous testing, ICG DCE-FI will lead to an entirely new methodology for rapid identification of patients with NSTIs, which will ultimately reduce patient morbidity and improve survival.",[57],"Necrotizing Fascitis","2026-03-17",{"date":60,"type":37},"2026-03-19",{"date":62,"type":37},"2025-09-26",{"date":64,"type":20},"2030-07",{"name":43,"class":44},8,""]