What side effects are associated with this type of intervention?

Common treatments for cancer, such as surgical resection, chemotherapy, radiation therapy, and targeted therapies, have various side effects. Surgical resection can lead to complications like infection, bleeding, and pain. Chemotherapy often causes myelotoxicity, including neutropenia and thrombocytopenia, as well as gastrointestinal issues, alopecia, and peripheral neuropathy. Radiation therapy can result in chronic radiation dermatitis, ulceration, and an increased risk of secondary malignancies. Targeted therapies, such as tyrosine kinase inhibitors, may cause side effects like hypertension, hand-foot syndrome, and liver toxicity. These side effects vary in severity and frequency depending on the specific treatment and patient factors.

What prior FDA approvals exist?

The FDA has approved various diagnostic dyes and imaging agents for cancer treatment, similar to Indocyanine Green (ICG) used for tumor margin visualization. These agents help in accurately identifying and resecting tumors during surgery. For instance, the FDA has approved the use of technetium-99m for sentinel lymph node mapping in breast cancer and melanoma. Additionally, other imaging agents like fluorodeoxyglucose (FDG) used in PET scans are widely approved for detecting and monitoring various cancers. These diagnostic tools enhance the precision of surgical interventions and improve oncologic outcomes.

What other types of research exist?

Promising alternatives to Indocyanine Green (ICG) for tumor margin visualization include 5-aminolevulinic acid (5-ALA) and autofluorescence laparoscopy. 5-ALA has been FDA-approved for glioma surgery and has shown to enhance the extent of resection and improve outcomes. Autofluorescence laparoscopy has been explored for detecting peritoneal endometriotic lesions and may have potential applications in cancer surgery.

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Dye

ICG Dye Imaging for Cancer Surgery

Phase 2

Recruiting

Led By Santiago A Lozano-Calderon, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.

Be older than 18 years old

Must not have

Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special dye called ICG to help surgeons see and remove bone or soft tissue tumors more effectively. The dye lights up the tumor under a special camera, making it easier to ensure all of it is removed. This approach aims to improve surgical outcomes for patients.

Who is the study for?

This trial is for adults over 18 with benign or malignant bone or soft tissue masses who are undergoing surgery at Massachusetts General Hospital's Orthopaedic Surgery Department. It excludes those in renal failure not cleared for ICG, pregnant or nursing individuals, and patients with known anaphylaxis to IV contrast or iodine.

What is being tested?

The study tests the effectiveness of using a dye called indocyanine green (ICG) during surgical removal of tumors to achieve clear margins. The goal is to see if this method reduces local recurrence, delays metastasis, and improves survival rates compared to traditional methods.

What are the potential side effects?

Potential side effects may include allergic reactions in those sensitive to dyes like ICG. Since it's used intraoperatively, risks are generally related to the procedure itself rather than long-term medication use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older with a bone or soft tissue mass and am scheduled for surgery at Massachusetts General Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My doctor says I can't have ICG due to kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

image-guided prediction of local recurrence

Secondary study objectives

Distant recurrence (metastatic disease)

physician-perceived vs. device measured negative margins

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: ICG Dye and use of SPY-PHI ImagingExperimental Treatment2 Interventions

ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

2016

Completed Phase 4

~1720

0 / 2Eligibility criteria met

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

Cancer treatments often target specific mechanisms to inhibit tumor growth and spread. For example, angiogenesis inhibitors block the formation of new blood vessels that tumors need to grow, while immunotherapies enhance the body's immune response to target and destroy cancer cells. Targeted therapies, such as those inhibiting EG-VEGF receptors or the PI3K pathway, focus on specific molecular pathways involved in cancer progression. Indocyanine Green (ICG) is a fluorescent dye used for tumor margin visualization during surgery, helping surgeons to more accurately remove cancerous tissues while sparing healthy ones. This precision is crucial for reducing recurrence rates and improving overall outcomes for cancer patients.

Current trends and future directions in the genetic therapy of human neoplastic disease.Anti-tumor activity of dual inhibition of phosphatidylinositol 3-kinase and MDM2 against clear cell ovarian carcinoma.Antagonism of EG-VEGF Receptors as Targeted Therapy for Choriocarcinoma Progression In Vitro and In Vivo.