Real-time detection of necrotizing soft tissue infection using indocyanine green imaging
Official title: Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Run by Dartmouth-Hitchcock Medical Center · NCT06877793 · Data updated 2026-11-12
We will test whether injecting indocyanine green and tracking its fluorescence over time can quickly and accurately detect necrotizing soft tissue infections in adults suspected of having NSTI.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Status | Recruiting |
| Started | September 26, 2025 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06877793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are admitted or evaluated for suspected NSTI and who are undergoing biopsy, observation, or surgical debridement and can give written informed consent are the intended participants.
✕Probably not a fit
People with a known allergy to ICG or iodine, pregnant or nursing women, and patients without clinical suspicion of NSTI are unlikely to benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multicenter project gives adults with suspected NSTI an intravenous dose of indocyanine green (ICG) and records near-infrared fluorescence over time to analyze ICG kinetic patterns. Investigators will use kinetic modeling of ICG perfusion to identify signatures of tissue necrosis and compare those imaging results to surgical findings, pathology, and clinical diagnoses. Imaging is performed during hospital evaluation or surgery without changing standard-of-care treatment decisions. The work is being done at UCLA, Stanford, and Emory/Grady to collect real-world data across multiple centers.
Why it matters
Potential benefit: If successful, the method could allow faster, more accurate diagnosis of NSTI so patients get earlier surgery and fewer delays that increase risk of death.
How similar studies have gone: ICG has a long safety record and is widely used for perfusion imaging, but applying ICG kinetic modeling specifically for real-time NSTI diagnosis is a novel approach supported mainly by limited preliminary data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Clinical suspicion of NSTI based on the local standard of care warranting: * Hospital admission for observation due to suspected NSTI; and/or * Soft tissue biopsy to rule in/out suspected NSTI; and/or * Surgical debridement for suspected NSTI; and/or * Specific institutional threshold criteria for triggering NSTI work-up; and * Ability to give written informed consent. Exclusion Criteria: * History of allergy to ICG and/or iodine. * Pregnant women or nursing mothers.
Where it's running
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University of California, Los Angeles
Los Angeles, California, United States Recruiting -
Stanford University
Stanford, California, United States Recruiting -
Emory University/Grady Memorial Hospital
Atlanta, Georgia, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Show 2 more locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
Vanderbilt University
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Eric R Henderson, MD
- Email: Eric.R.Henderson@hitchcock.org
- Phone: 603-650-5133
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.