Using ICG dye to improve tumor margin identification during surgery
Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Run by Massachusetts General Hospital · NCT04752137 · Data updated 2026-11-12
This study tests whether using a special dye during surgery can help doctors see tumor edges better and improve outcomes for patients with bone or soft tissue tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 25, 2022 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2030 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT04752137 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with benign or malignant bone or soft tissue masses scheduled for surgery at Massachusetts General Hospital.
✕Probably not a fit
Patients who are pregnant, nursing, or have known allergies to IV contrast or iodine may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of indocyanine green (ICG) dye in identifying tumor margins during the surgical resection of benign and malignant bone or soft tissue masses. Patients will receive ICG via injection before surgery, and its fluorescence will be monitored during the procedure to ensure complete tumor removal. The study aims to determine if ICG-guided resection leads to better oncologic outcomes, including local recurrence and overall survival rates.
Why it matters
Potential benefit: If successful, this approach could lead to more effective tumor resections and improved patient outcomes.
How similar studies have gone: Other studies using ICG for tumor margin identification have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period. Exclusion Criteria: * Pregnant or nursing patients * Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis) * Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Santiago A Lozano-Calderon, MD, PhD — Massachusetts General Hospital
- Study coordinator: Santiago A Lozano-Calderon, MD, PhD
- Email: SLOZANOCALDERON@mgh.harvard.edu
- Phone: (617) 643-4947
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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.