Clinical trial · Interventional
Fluorescent Intra-operative Tumor Margin Examination
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green solution administered at 2.0mg/kg. | Drug | — | UNRESOLVED |
| Stryker SPY-PHI Imaging Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ICG use followed by SPY-PHI imaging.
- description
- Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology.
- interventionNames
- Drug: Indocyanine green solution administered at 2.0mg/kg.
- Device: Stryker SPY-PHI Imaging Device
Primary outcomes (1)
- measure
- Tumor recurrence as predicted by the surgeon vs. identified with SPY.
- timeFrame
- During surgery for tumor removal
- description
- The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.
Secondary outcomes (1)
- measure
- Comparison of ICG angiography with pathologic evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available