Indocyanine Green for Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor; Neoplasms
• Interventions: Drug: Indocyanine Green (ICG)

• Registration Number: NCT02280954
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-11-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG injection group	Indocyanine Green (ICG)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of participants that will have an adverse reaction to the ICG.	Day 1-Day 30

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States