Indocyanine Green for Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2013 |
| End Date: | February 2017 |
A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green
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.
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.
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).
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Sunil Singhal, M.D.
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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