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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
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
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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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,540,051 Total Patients Enrolled
Eric R Henderson, MDPrincipal InvestigatorDartmouth-Hithcock Medical Center
2 Previous Clinical Trials
27 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to iodine.
Research Study Groups:
This trial has the following groups:- Group 1: Benign Bone patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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