Fluorescent Intra-operative Tumor Margin Examination

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Kurt Weiss
Study ID
NCT04719156
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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.
  • Stryker SPY-PHI Imaging Device — DEVICE
    The SPY-PHI system is used with the ICG dye to provide fluorescence images.

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC-Shadyside HospitalPittsburghPennsylvania15213
Beata Krawczyk, MS
412-802-4100

Find similar trials in Pittsburgh, PA

By research site
UPMC-Shadyside Hospital· Pittsburgh, PA

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