NCT04719156RecruitingPhase 2
Fluorescent Intra-operative Tumor Margin Examination
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 6 Jan 2021
- Start date
- 2 Mar 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Kurt Weiss
- Diseases
- Sarcoma
- NCT number
- NCT04719156
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 110
- From 2 Mar 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgery local to the mass being excised
Other illness
- Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
- Dialysis, renal failure, uremia
Age
- Patients below the age of 18
Other
- Pregnancy, breast feeding
- Non- or minimally-recurrent masses (i.e. osteochondroma)
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC-Shadyside Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.