Using fluorescent dye to improve tumor margin examination during sarcoma surgery
Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Run by University of Pittsburgh · NCT04719156 · Data updated 2026-11-12
This study is testing if a special dye can help surgeons see tumor edges better during sarcoma surgery to make sure they remove all the cancerous tissue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | March 2, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT04719156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with a biopsy-confirmed primary musculoskeletal tumor indicated for surgical excision.
✕Probably not a fit
Patients under 18, pregnant or breastfeeding individuals, and those with certain medical conditions or prior surgeries near the tumor site 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 use of indocyanine green (ICG) dye to enhance the identification of tumor margins during surgical excision of sarcomas. Participants will receive an injection of ICG prior to surgery, and the accuracy of the dye in highlighting residual tumor tissue will be assessed using ICG angiography. The goal is to improve the precision of tumor removal and reduce the likelihood of leaving behind cancerous tissue. The study aims to provide real-time feedback to surgeons about the completeness of tumor excision.
Why it matters
Potential benefit: If successful, this approach could lead to more effective surgical outcomes by ensuring complete removal of tumors, potentially reducing recurrence rates.
How similar studies have gone: Previous studies have shown promising results using ICG for tumor margin assessment, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist. * Surgical consent was obtained prior to research consent. * Patients with a biopsy-confirmed primary soft tissue or bone tumor that has not been previously excised and has a known risk of local or remote recurrence. Exclusion Criteria: * Patients below the age of 18 * Pregnancy, breast feeding * Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy * Prior surgery local to the mass being excised * Non- or minimally-recurrent masses (i.e. osteochondroma) * Dialysis, renal failure, uremia
Where it's running
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UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Kurt E Weiss — University of Pittsburgh
- Study coordinator: Beata Krawczyk, krawbx@upmc.edu
- Email: krawbx@upmc.edu
- Phone: 412-401-3000
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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.