Real-time detection of necrotizing soft tissue infection using indocyanine green imaging
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
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 |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT06877793 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 7 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Not_yet_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)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.