Neoplasms, Solid Tumor
Conditions
Keywords
Solid Tumor
Brief summary
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.
Interventions
DRUGIndocyanine Green (ICG)
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Before surgery |
Secondary
| Measure | Time frame |
|---|---|
| The number of participants that will have an adverse reaction to the ICG. | Day 1-Day 30 |
Countries
United States
Outcome results
None listed