22 Participants NeededMy employer runs this trial

Fluorescence-Guided Surgery for Sarcoma

Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons remove sarcomas, a type of cancer, more effectively. It compares regular surgery to Fluorescence-Guided Surgery, where a special dye, Indocyanine Green, illuminates the tumor, aiding surgeons in its complete removal. This approach could reduce the risk of leaving cancer cells behind. Individuals diagnosed with intermediate to high-grade sarcoma and planning surgery may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

What prior data suggests that fluorescence-guided surgery is safe for sarcoma patients?

Research has shown that fluorescence-guided surgery (FGS) with indocyanine green is generally safe and well-tolerated. Indocyanine green, a dye, helps surgeons identify cancerous tissue during surgery. Surgeons have successfully used this technique in other cancer surgeries to remove more cancer while preserving healthy tissue.

Studies have found that FGS can reduce the likelihood of leaving cancerous cells behind after surgery, which is crucial for lowering the risk of cancer recurrence. The method's safety is supported by its use in numerous surgeries, with no significant safety concerns reported.

In summary, evidence suggests that fluorescence-guided surgery with indocyanine green is a safe option for patients undergoing sarcoma surgery, with no major adverse events reported.12345

Why are researchers excited about this trial's treatment?

Fluorescence-Guided Surgery (FGS) is unique because it uses a special dye called indocyanine green (ICG) to make cancer cells light up during surgery. This innovative approach allows surgeons to see and remove cancerous tissue more precisely than with standard surgical techniques alone. Researchers are excited because FGS has the potential to reduce the risk of leaving behind cancer cells, which can lead to better outcomes and fewer repeat surgeries for patients with sarcoma.

What evidence suggests that fluorescence-guided surgery is effective for reducing unexpected positive margins in sarcoma?

This trial will compare standard surgical resection with fluorescence-guided surgery (FGS) for sarcoma. Research has shown that FGS, using a dye called indocyanine green, helps surgeons distinguish between cancerous and healthy tissue. This method reduces the chances of leaving cancer cells behind by lowering positive margin rates. One study found that FGS makes it easier for doctors to remove all the cancer, often eliminating the need for a second surgery. In various types of cancer, FGS has greatly improved the accuracy of tumor removal. This suggests that FGS could effectively treat sarcoma by enhancing surgical success.678910

Who Is on the Research Team?

TL

Thinzar Lwin

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people of any age with a confirmed intermediate to high grade soft tissue sarcoma who are planning to have surgery to try and cure the cancer. Participants must be able to give consent, answer surveys, and allow review of their medical records. People with certain allergies, specific tumor locations, or those who are pregnant or breastfeeding cannot join.

Inclusion Criteria

Willingness to permit medical record/clinical laboratory result review
Documented written informed consent of the participant
Willingness to respond to surveys during the trial
See 3 more

Exclusion Criteria

Known allergies to ICG, iodine, iodine dyes or shellfish
I am scheduled for surgery to relieve symptoms, not to cure my condition.
My cancer is located in the brain, abdomen, or internal organs.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either standard of care surgical resection or fluorescence-guided surgery with indocyanine green

During surgical resection
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up visits at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Fluorescence-Guided Surgery
  • Indocyanine Green

Trial Overview

The study compares standard surgery for sarcoma removal with a newer method that uses a special dye (indocyanine green) and fluorescent imaging during surgery. This helps surgeons better see the tumor edges in real time, aiming to reduce leftover cancer cells at the margins.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (FGS)Experimental Treatment5 Interventions
Group II: Arm I (standard of care)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Diagnostic accuracy and surgical outcomes of fluorescence ...

FGS demonstrates tangible clinical impact by moderately improving diagnostic accuracy and reducing both positive margin and reoperation rates.

Fluorescence-Guided Surgery May Soon Extend Beyond ...

The results revealed effective use at a range of dosages with few adverse events. In some ways, the study reflects dominant patterns in FGS: it ...

Consensus conference statement on fluorescence-guided ...

Pooled consensus for agreement was achieved in 5 out of 7 (71%) statements related to ICG-based fluorescence imaging for tissue perfusion (Table ...

Efficacy and Safety of Fluorescence-Guided Surgery ...

This systematic review and meta-analysis aimed to assess the safety and efficacy of fluorescence-guided surgery in the management of colorectal ...

Review Article Exploring the impact of neoadjuvant therapy ...

The data suggest that fluorescence is preserved in tumors with limited response, while effective therapy resulting in extensive necrosis may impair tracer ...

Development of Methods for Subsurface Visualization of Cancers

Orthopaedics & Sports Medicine Grand Rounds - Wednesday, July 12, 2017 “Direct Fluorescence-Guided Surgery: Development of Methods for ...

Fluorescence Image-Guided Surgery and Cancer

Fluorescence image-guided surgery is a cutting-edge scientific technique that is improving the success of cancer surgeries, helping to detect ...

Fluorescence-Guided Surgical Resection for Reducing ...

Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma. Recruiting in the following locations ...

Consensus conference statement on fluorescence-guided ...

Consensus was achieved in 17 out of 36 (45%) statements with highest level of agreement for application of FGS in tissue perfusion and biliary/ ...

10.

digitalcommons.dartmouth.edu

digitalcommons.dartmouth.edu/facoa/3964/

Application of Fluorescence-Guided Surgery to Subsurface ...

Positive margin rates in sarcoma resection remain in the range of 20% to 35% and are associated with increased recurrence and decreased survival ...