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NCT06877793 · ClinicalTrials.gov registry record
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
A clinical trial of Necrotizing Fascitis, sponsored by Eric R. Henderson.
- Recruiting
- Registry status
- 420
- Enrollment target
- 8
- Study locations
NCT06877793 is a study of Necrotizing Fascitis that is actively recruiting participants, run by Eric R. Henderson. The registered enrollment target is 420 participants. The trial reports 8 study locations across 6 states.
The verdict
NCT06877793, a study of Necrotizing Fascitis, is actively recruiting participants, sponsored by Eric R. Henderson.
- RECRUITING
- Registry status
- 420 participants
- Enrollment target
- 8
- Study locations
Study Summary
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/regi
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Administration of indocyanine green (ICG) and fluorescence imaging
Study Locations (8)
California
- University of California, Los Angeles - Los Angeles
- Stanford University - Stanford
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Georgia
- Emory University/Grady Memorial Hospital - Atlanta
Michigan
- University of Michigan - Ann Arbor
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2030-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06877793
The ClinicalTrials.gov registry entry for NCT06877793 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eric R. Henderson, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Necrotizing Fascitis appearing as the primary indexed condition, and to 1 intervention - of which Administration of indocyanine green (ICG) and fluorescence imaging is the first listed.
NCT06877793 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, Pennsylvania, Georgia.
Frequently Asked Questions
What is clinical trial NCT06877793 about?
NCT06877793 is a clinical study titled "Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling". 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...
What is the current status of trial NCT06877793?
This trial is currently recruiting. The enrollment target is 420 participants. The study started on 2025-09-26. Estimated completion is 2030-07.
What conditions does trial NCT06877793 study?
This clinical trial studies the following conditions: Necrotizing Fascitis.
What interventions are being tested in trial NCT06877793?
The interventions under investigation include: Administration of indocyanine green (ICG) and fluorescence imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06877793?
This trial is sponsored by Eric R. Henderson, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06877793 being conducted?
This trial has 8 study locations across California, Georgia, Michigan, New Hampshire, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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