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Completed

NCT Number: NCT02280954

Indocyanine Green for Solid Tumors

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.

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Key information

Conditions

Solid Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients over 18 years of age
  • Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment
  • Good operative candidate as determined by the treating physician and multidisciplinary team
  • Subject capable of giving informed consent and participating in the process of consent.

Exclusion criteria

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  • Subjects with a history of iodide allergies
  • Vulnerable patient populations
  • People who would be easily lost to follow up
  • Patients unable to participate in the consent process (children and neonates).

Treatment and study plan

Indocyanine Green (ICG)

Drug

Other names: ICG

Primary outcomes

  1. 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.

    Time frame: Before surgery

Secondary outcomes

  1. The number of participants that will have an adverse reaction to the ICG.

    Time frame: Day 1-Day 30

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: 818012

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2014
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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