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Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)

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ClinicalTrials.gov Identifier: NCT01796041
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

January 18, 2013
February 21, 2013
February 5, 2018
July 2011
November 9, 2016   (Final data collection date for primary outcome measure)
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)
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)
Complete list of historical versions of study NCT01796041 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Intraoperative Imaging of Breast Cancer With Indocyanine Green
A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery
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.
Not Provided
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Invasive Ductal Carcinoma
  • Invasive Lobular Carcinoma
  • Ductal Carcinoma
Drug: Indocyanine Green
Other Names:
  • ICG
  • The chemical formula is C45H47N2O6S2Na
Experimental: IV Injection of ICG
Intervention: Drug: Indocyanine Green
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
November 9, 2016
November 9, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01796041
UPCC 12111
813695 ( Other Identifier: UPenn IRB Protocol # )
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Not Provided
University of Pennsylvania
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP