Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01796041
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Invasive Ductal Carcinoma Invasive Lobular Carcinoma Ductal Carcinoma Drug: Indocyanine Green Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IV Injection of ICG Drug: Indocyanine Green
Other Names:
  • ICG
  • The chemical formula is C45H47N2O6S2Na

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Evaluation [ Time Frame: 0-5 years after surgery ]
    C) evaluate progression free survival in our study cohorts

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy).
  3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates.
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam)
  2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  3. Subjects with a history of iodide allergies
  4. At-risk patient populations

    1. Homeless patients
    2. Patients with drug or alcohol dependence
    3. Patients unable to participate in the consent process

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01796041

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

Responsible Party: University of Pennsylvania Identifier: NCT01796041     History of Changes
Other Study ID Numbers: UPCC 12111
813695 ( Other Identifier: UPenn IRB Protocol # )
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases