Using fluorescent dye to improve tumor margin examination during sarcoma surgery
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
PHASE2 · University of Pittsburgh · NCT04719156
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04719156 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a biopsy-confirmed primary musculoskeletal tumor indicated for surgical excision.
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.
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 performed: Previous studies have shown promising results using ICG for tumor margin assessment, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
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.
Conditions: Sarcoma