Using ICG dye to improve tumor margin identification during surgery
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04752137 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, nursing, or have known allergies to IV contrast or iodine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective tumor resections and improved patient outcomes.
How similar studies have performed: Other studies using ICG for tumor margin identification have shown promising results, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
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.