What side effects are associated with this type of intervention?

Indocyanine Green (ICG) is generally well-tolerated and used for enhanced tumor visualization during surgery, with minimal side effects such as mild allergic reactions. Common treatments for bone tumors include surgery, chemotherapy, and radiation therapy. Surgical treatments can lead to complications like infection, bleeding, and delayed wound healing. Chemotherapy may cause side effects such as nausea, vomiting, hair loss, and increased risk of infection. Radiation therapy can result in skin changes, fatigue, and long-term risks like secondary cancers and tissue fibrosis. Combining these treatments aims to maximize tumor control while managing side effects.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of bone tumors similar to the use of Indocyanine Green (ICG) for enhanced tumor visualization. However, it does reference the use of ICG in a clinical trial setting for benign bone tumors. Generally, treatments for bone tumors may include surgical resection, chemotherapy, and targeted therapies, but specific FDA-approved drugs for bone tumors were not detailed in the context.

What other types of research exist?

Promising alternatives to Indocyanine Green for enhanced tumor visualization in bone tumors include 5-aminolevulinic acid (5-ALA) and its derivatives. 5-ALA has been shown to improve the extent of tumor resection and patient outcomes in various cancers, including gliomas. Additionally, novel imaging techniques such as intraoperative MRI and fluorescence-guided surgery using other targeted fluorescent agents are also being explored and show potential for better visualization and resection of bone tumors.

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Indocyanine Green Dye for Bone Tumors

Phase < 1

Waitlist Available

Led By Eric R Henderson, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post injection

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special dye that lights up under a camera to help doctors see blood flow and tissue health during surgery. It targets patients with benign bone tumors who are having surgery. The dye shows detailed images of blood vessels, helping ensure precise and effective surgery.

Who is the study for?

This trial is for patients aged 12 or older with benign bone tumors, such as Enchondroma or Osteochondroma, among others. They must consent to treatment and not be pregnant, breastfeeding, incarcerated, or allergic to iodine. The tumor should be manageable with intralesional surgery.

What is being tested?

The study tests the use of Indocyanine Green (ICG), an FDA-approved dye given intravenously before surgery. It aims to see if ICG helps visualize the tumor better during operation using a special fluorescence camera.

What are the potential side effects?

Potential side effects of ICG include mild reactions at the injection site and rare cases of allergy-like symptoms due to iodine content in the dye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fluorescent intensity contrast

Awards & Highlights

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: Benign Bone patientsExperimental Treatment1 Intervention

Patients with Benign Bone tumors requiring intralesional operative management will be administered immunofluorescent indocyanine green 24 hours prior to surgery, imaging of perfused tissues will be performed at the time of tumor removal.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine Green

2008

Completed Phase 2

~1050

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bone tumors include surgery, chemotherapy, and radiation therapy. Surgery often involves resection of the tumor, which can be enhanced by using fluorescent dyes like Indocyanine Green (ICG) to improve visualization and ensure complete removal. Chemotherapy uses cytotoxic agents to kill cancer cells, while radiation therapy uses high-energy rays to target and destroy tumor cells. The use of ICG in surgery is particularly important for bone tumor patients as it allows for more precise removal of the tumor, reducing the risk of recurrence and preserving healthy tissue, which is crucial for maintaining bone function and overall quality of life.

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