Indocyanine Green for Solid Tumors (818012)

University of Pennsylvania

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Neoplasms

Treatments: Drug: Indocyanine Green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02280954

818012

818012 [UPenn IRB Protocol#] (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

ICG injection group

Experimental group

Description:

This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed.

Treatment:

Drug: Indocyanine Green (ICG)