Evaluation of Intraoperative Tumor Margin Identification with Fluorescent Dye Imaging

Who is this study for? Adult patients with a Primary Muscoloskeletal Tumor
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Beata Krawczyk, krawbx@upmc.edu
krawbx@upmc.edu
412-401-3000
Backup
Kurt Weiss, MD
weiskr@upmc.edu
4128024100
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 110
Treatments
Other: ICG use followed by SPY-PHI imaging.
Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology.
Related Therapeutic Areas
Sponsors
Collaborators: Stryker Nordic
Leads: Kurt Weiss

This content was sourced from clinicaltrials.gov

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