Indocyanine Green for Solid Tumors

Neoplasms Clinical Trial

— 818012  

Official title:

A Pilot and Feasibility Study of Intraoperative Imagery of Solid Tumors With Indocyanine Green

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280954
• Other study ID #: 818012
• Secondary ID: 818012 [UPenn IR
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2013
• Last updated: March 16, 2018
• Start date: November 2013
• Est. completion date: February 2017

Study information

• Verified date: March 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Indocyanine Green (ICG)

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of participants that will have an adverse reaction to the ICG.		Day 1-Day 30