Clinical Trial: Intraoperative Imaging of Breast Cancer With Indocyanine Green

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery

Brief Summary: According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome: Identification [ Time Frame: After infusion of ICG ]

The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)


Original Primary Outcome: Identification [ Time Frame: 24 hours after infusion of ICG ]

The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)


Current Secondary Outcome:

  • Evaluation [ Time Frame: 0-5 years after surgery ]
    a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.
  • Evaluation [ Time Frame: 0-5 years after surgery ]
    b) evaluate the rate of re-excision in participants compared to a matched case- control cohort with similar clinicopathological characteristics undergoing breast conservation surgery.
  • Evaluation [ Time Frame: 0-5 years after surgery ]
    C) evaluate progression free survival in our study cohorts


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: January 18, 2013
Date Started: July 2011
Date Completion: February 2018
Last Updated: May 13, 2016
Last Verified: May 2016