Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)
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.
Invasive Ductal Carcinoma
Invasive Lobular Carcinoma
Drug: Indocyanine Green
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery|
- Identification [ Time Frame: After infusion of ICG ] [ Designated as safety issue: No ]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)
- Evaluation [ Time Frame: 0-5 years after surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]C) evaluate progression free survival in our study cohorts
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: IV Injection of ICG||
Drug: Indocyanine Green
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796041
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sunil Singhal firstname.lastname@example.org|
|Principal Investigator: Sunil Singhal, M.D.|