50 Participants Needed

Indocyanine Green Dye for Soft Tissue Sarcoma

CT
LD
Overseen ByLaura Dohrmann
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a special dye and light during surgery can help doctors ensure complete removal of a bone or soft tissue tumor. The dye, indocyanine green, illuminates the tumor area, allowing surgeons to check their work more accurately. This is crucial for patients with sarcoma, a cancer affecting bones and soft tissues. Individuals with a confirmed sarcoma diagnosis and scheduled for surgery might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in sarcoma treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that intraoperative indocyanine green dye fluorescence angiography is safe?

A previous study demonstrated that indocyanine green (ICG) dye is safe for use in surgery. Researchers found it helpful for checking blood flow and tissue health. The study suggested that patients generally tolerate ICG well.

Another review examined its use in surgeries and found it to be a useful and safe tool, with no major side effects reported.

While some research on ICG's effectiveness in certain situations remains mixed, its safety record is strong. It is even considered safe for use in children. This evidence suggests that ICG dye is a safe option for helping surgeons achieve the desired results.12345

Why are researchers excited about this trial?

Researchers are excited about using intraoperative indocyanine green (ICG) dye fluorescence angiography for sarcoma surgeries because it offers a cutting-edge way to visualize blood flow and tissues in real-time during surgery. Unlike standard imaging techniques, ICG dye fluoresces under infrared light, helping surgeons to clearly identify and remove tumor tissue while preserving healthy tissue. This precise technique could potentially improve surgical outcomes and reduce recurrence rates by ensuring more complete tumor resections.

What evidence suggests that intraoperative indocyanine green dye fluorescence angiography is effective for confirming negative margins after tumor removal?

Research has shown that using a special dye called indocyanine green (ICG) during surgery can enhance visibility for surgeons. This technique may lead to more precise tumor removal. Some studies suggest it can reduce complications, such as leaks where two pieces of tissue are joined. By improving blood flow during surgery, it might also decrease the need for additional procedures like creating openings for waste removal. While results are promising for some surgeries, they vary, and further research is needed to confirm its effectiveness for different types of cancer surgeries. Participants in this trial will receive an ICG infusion before their scheduled resection, and their medical records will be reviewed as part of the study.36789

Who Is on the Research Team?

MT

Matthew T. Houdek, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

I am having surgery for my diagnosed bone or soft tissue sarcoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive ICG infusion prior to undergoing scheduled resection

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Intraoperative Indocyanine Green Dye Fluorescence Angiography

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ObservationalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27553790/

Indocyanine green fluorescence angiography during ...

In our experience, ICG FA was safe and effective in low rectal cancer resection, possibly leading to a reduction in the anastomotic leakage rate after TME.

Intraoperative fluorescence angiography with indocyanine ...

Data are mixed on whether indocyanine green (ICG) fluorescence angiography can reduce the high rate of anastomotic leaks in patients ...

Indocyanine Green Fluorescence Angiography and the... : ...

The purpose of this study was to investigate whether intraoperative indocyanine green fluorescence angiography can reduce the incidence of anastomotic leak.

Indocyanine green fluorescence angiography for bowel ...

By allowing surgeons to assess perfusion intraoperatively, ICG-FA may help reduce anastomotic leaks and decrease the need for diverting ostomies, with the goal ...

A narrative review of intraoperative use of indocyanine green ...

The use of ICG fluorescence imaging can improve the accuracy of tumor resection and potentially improve surgical outcomes for cancer patients.

Efficacy and safety of indocyanine green fluorescence ...

This meta-analysis aims to evaluate the impact of indocyanine green (ICG) fluorescence imaging on surgical outcomes compared to conventional ( ...

Safety and Feasibility of Indocyanine Green Fluorescence ...

The results of this systematic review suggest that ICG may be a useful and safe intervention for evaluation of anastomotic blood flow, evaluation of vitality of ...

Current applications of indocyanine green fluorescence ...

This systematic review gives an overview of current applications of ICG-FA in surgical treatment of traumatic injury and its effects on the incidence of ...

The Use of Indocyanine Green Fluorescence Angiography ...

Based on our results, ICG-FA technology is a promising surgical tool and appears safe for usage in pediatric patients. However, small sample ...