Fluorescent Intra-operative Tumor Margin Examination

NCT04719156 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: STUDY19110051
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Tumor recurrence as predicted by the surgeon vs. identified with SPY.

  The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.

  During surgery for tumor removal

Secondary Outcomes (1)

• Comparison of ICG angiography with pathologic evaluation

  Over a two year follow up period

Study Arms (1)

ICG use followed by SPY-PHI imaging.

OTHER

Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology.

Drug: Indocyanine green solution administered at 2.0mg/kg.; Device: Stryker SPY-PHI Imaging Device

Interventions

Indocyanine green solution administered at 2.0mg/kg. DRUG

Dosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery.

Also known as: Indocyanine Green for Injection

ICG use followed by SPY-PHI imaging.

Stryker SPY-PHI Imaging Device DEVICE

The SPY-PHI system is used with the ICG dye to provide fluorescence images.

Also known as: Stryker SPY portable Imaging System

ICG use followed by SPY-PHI imaging.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kurt Weiss: lead
• Stryker Nordic: collaborator

Study Sites (1)

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kurt E Weiss

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beata Krawczyk, krawbx@upmc.edu

CONTACT

412-401-3000; krawbx@upmc.edu

Kurt Weiss, MD

CONTACT

4128024100; weiskr@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Operating surgeon will be blinded to ICG Images.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, Director, Musculoskeletal Oncology Lab

Model Details: Patients with suspected sarcoma tumors.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 22, 2021
• Study Start: March 2, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)