Fluorescent Intra-operative Tumor Margin Examination

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kurt Weiss
• Collaborator: Stryker Nordic

Criteria

Inclusion Criteria:

• Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision.

• 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 an iodine or fluorescein allergy

• Patients with a recurrent or metastatic tumor

• Pre-operative radiotherapy

• Patients being managed for a local recurrence

• Prior surgery local to the mass being excised

• Non- or minimally-recurrent masses (i.e. osteochondroma)

• Dialysis, renal failure, uremia