Recruiting
Phase 2

ICG

Sponsor:

Kurt Weiss

Code:

NCT04719156

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Indocyanine green solution administered at 2.0mg/kg.

Stryker SPY-PHI Imaging Device

Study Details

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

Study ID

NCT04719156

Start date

Mar 2, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Indocyanine green solution administered at 2.0mg/kg.

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

Stryker SPY-PHI Imaging Device

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

Primary outcome measure

  • Tumor recurrence as predicted by the surgeon vs. identified with SPY. [ Time Frame: During surgery for tumor removal ]

Central Contacts and Locations

Central contacts

Beata Krawczyk, krawbx@upmc.edu

412-401-3000krawbx@upmc.edu

Locations

UPMC-Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Beata Krawczyk, MS

412-802-4100

More Information

Sponsor

Kurt Weiss

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kurt Weiss on 2026-02-20.