Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-27 @ 1:38 AM
Study NCT ID:
NCT06877793
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019115', 'term': 'Fasciitis, Necrotizing'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061848', 'term': 'Optical Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if tissue perfusion, determined by first-pass ICG fluorescence kinetics, is reliably reduced in the setting of a necrotizing infection compared to a non-necrotizing infection.', 'timeFrame': 'From enrollment to the end of fluorescence imaging (about 1 day)', 'description': 'We will evaluate first-pass fluorescence signal intensity changes from indocyanine green (ICG), a vascular perfusion fluorophore, in the setting of severe soft-tissue infections to determine if ICG fluorescence may be an accurate and reliable diagnostic test for differentiating life-threatening necrotizing infections from non-life-threatening non-necrotizing infections.'}], 'secondaryOutcomes': [{'measure': 'Determine if first-pass ICG fluorescence kinetics in patients with necrotizing infections vary based on the causative bacterial species.', 'timeFrame': 'From enrollment to the end of imaging and lab results (about 30 days)', 'description': "In patients who had a documented necrotizing soft-tissue infection, we will compare first-pass fluorescence signal intensity changes from ICG based on the predominant causative bacterial species isolated from a patient's infection to determine if ICG signal changes vary by species."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Necrotizing Fascitis']}, 'descriptionModule': {'briefSummary': '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/regions 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/imaging 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the ED or clinic who are considered at intermediate- or high-risk for NSTI.', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or\n* Soft tissue biopsy to rule in/out suspected NSTI; and/or\n* Surgical debridement for suspected NSTI; and/or\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/or iodine.\n* Pregnant women or nursing mothers.'}, 'identificationModule': {'nctId': 'NCT06877793', 'briefTitle': 'Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling', 'orgStudyIdInfo': {'id': '02002719'}, 'secondaryIdInfos': [{'id': '1R01AI184513-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI184513-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of indocyanine green (ICG) and fluorescence imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with clinical and lab findings consistent with a diagnosis of NSTI who consent to this study will receive a one-time, weight-appropriate dose of ICG (0.2 mg/kg, in accordance with FDA-approved recommendations). Each patient will undergo fluorescence imaging immediately before and after administration of ICG.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Lee, MD', 'role': 'CONTACT', 'email': 'ChristopherLee@mednet.ucla.edu', 'phone': '310-319-1234'}, {'name': 'Christopher Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicholas Bernthal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Forrester, MD', 'role': 'CONTACT', 'email': 'jdf1@stanford.edu'}, {'name': 'Joseph Forrester, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ariel Knight, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgan Fuller', 'role': 'CONTACT', 'email': 'jaimo.ahn@emory.edu', 'phone': '(404) 251-8953'}, {'name': 'Jaimo Ahn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University/Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Hunter, MD', 'role': 'CONTACT', 'email': 'huntmary@med.umich.edu'}, {'name': 'Molly Hunter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raymond Jean, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric R Henderson, MD', 'role': 'CONTACT', 'email': 'Eric.R.Henderson@hitchcock.org', 'phone': '603-650-5133'}, {'name': 'Jonathan Elliot, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samuel S Streeter, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Macgregor Montano, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Scott Rodi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric R Henderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Niels Martin, MD, PhD', 'role': 'CONTACT', 'email': 'Niels.Martin@pennmedicine.upenn.edu'}, {'name': 'Niels Martin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sunil Singhal, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kurt Weiss, MD', 'role': 'CONTACT', 'email': 'weiskr@UPMC.EDU', 'phone': '(412) 802-4137'}, {'name': 'Kurt Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Schoenecker, MD, PhD', 'role': 'CONTACT', 'email': 'jon.schoenecker@vumc.org', 'phone': '(615) 936-3391'}, {'name': 'Jonathan Schoenecker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William Obremskey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eben Rosenthal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Eric R Henderson, MD', 'role': 'CONTACT', 'email': 'Eric.R.Henderson@hitchcock.org', 'phone': '603-650-5133'}, {'name': 'Morgan T Mazanec, MPH', 'role': 'CONTACT', 'email': 'Morgan.T.Mazanec@Hitchcock.ORG', 'phone': '603-308-9233'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will only be shared in aggregate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eric R. Henderson', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopaedics', 'investigatorFullName': 'Eric R. Henderson', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}