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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over a two year follow up period

Awards & highlights

ICGTM Trial 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.Check my eligibility

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.See study design

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.

ICGTM Trial 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.

ICGTM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over a two year follow up period

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Comparison of ICG angiography with pathologic evaluation

ICGTM 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kurt WeissLead Sponsor

Stryker NordicIndustry Sponsor

32 Previous Clinical Trials

3,985 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements to participate in this research?

"Candidates who are between 18 and 100 years of age with a diagnosis of sarcoma may be admitted to this clinical trial. Around 110 patients will take part in the study."

Answered by AI

Is it possible to participate in the study at this current time?

"According to the data hosted on clinicaltrials.gov, this healthcare investigation is currently recruiting patients. It was initially posted in March of 2021 and, most recently, revised in March of 2022."

Answered by AI

Is the current research project recruiting participants of advanced age?

"In order to qualify for this medical trial, participants must be aged 18 and above but not older than 100."

Answered by AI

What is the maximum number of participants for this research project?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants; it was initially posted on March 2nd 2021 and the last report was published on 11th of March 2022. The research team aims to recruit 110 individuals from a single medical facility."

Answered by AI

Has this therapy received the greenlight from federal regulators?

"Our team of professionals at Power rated this therapy's safety as a 2, due to the lack of clinical data proving its efficacy and only limited evidence confirming its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorescent Intra-operative Tumor Margin Examination

Kurt Weiss 2021. "Fluorescent Intra-operative Tumor Margin Examination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04719156.

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