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Fluorescent Tumor Margin Examination for Sarcoma (ICGTM Trial)

Phase 2
Recruiting
Led By Kurt E Weiss
Research Sponsored by Kurt Weiss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgical consent was obtained prior to research consent.
Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist.
Must not have
Non- or minimally-recurrent masses (i.e. osteochondroma)
Patients below the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over a two year follow up period
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing whether ICG can be used to identify tumor margins during surgery, which would be less expensive and time-consuming than the current standard of care.

Who is the study for?
This trial is for adults over 18 with primary musculoskeletal tumors scheduled for surgery. Candidates must have a tumor that hasn't been removed before and has a risk of coming back. It's not for those under 18, pregnant or breastfeeding women, people who've had previous surgery near the tumor, kidney failure patients, or anyone allergic to contrast media.
What is being tested?
The study tests if injecting indocyanine green (ICG) can help surgeons see cancerous tissue edges during sarcoma removal surgeries better than current methods. The Stryker SPY-PHI Imaging Device will be used to visualize the ICG-stained tissues in real-time.
What are the potential side effects?
Potential side effects may include allergic reactions to the ICG solution such as rash or anaphylaxis, especially in individuals with known allergies to similar substances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I gave my permission for surgery before agreeing to join the study.
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I am over 18 and need surgery for a bone or muscle tumor.
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My biopsy shows I have a primary soft tissue or bone tumor that hasn't been removed and could recur.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My tumor has not or barely come back after treatment.
Select...
I am under 18 years old.
Select...
I am on dialysis or have kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over a two year follow up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and over a two year follow up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor recurrence as predicted by the surgeon vs. identified with SPY.
Secondary study objectives
Comparison of ICG angiography with pathologic evaluation

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICG use followed by SPY-PHI imaging.Experimental Treatment2 Interventions
Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology.

Find a Location

Who is running the clinical trial?

Kurt WeissLead Sponsor
Stryker NordicIndustry Sponsor
34 Previous Clinical Trials
4,289 Total Patients Enrolled
Kurt E WeissPrincipal InvestigatorUniversity of Pittsburgh

Media Library

ICG use followed by SPY-PHI imaging. Clinical Trial Eligibility Overview. Trial Name: NCT04719156 — Phase 2
Sarcoma Research Study Groups: ICG use followed by SPY-PHI imaging.
Sarcoma Clinical Trial 2023: ICG use followed by SPY-PHI imaging. Highlights & Side Effects. Trial Name: NCT04719156 — Phase 2
ICG use followed by SPY-PHI imaging. 2023 Treatment Timeline for Medical Study. Trial Name: NCT04719156 — Phase 2
~0 spots leftby Dec 2024
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