Indocyanine Green for Solid Tumors

University of Pennsylvania48 enrolled

Overview

According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Solid Tumor Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients over 18 years of age 2. Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment 3. Good operative candidate as determined by the treating physician and multidisciplinary team 4. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: 1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery 2. Subjects with a history of iodide allergies 3. Vulnerable patient populations 1. People who would be easily lost to follow up 2. Patients unable to participate in the consent process (children and neonates).

Outcomes

Primary Outcomes

The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.

Time frame: Before surgery

Secondary Outcomes

The number of participants that will have an adverse reaction to the ICG.

Time frame: Day 1-Day 30