Status:
COMPLETED
Intraoperative Imaging of Breast Cancer With Indocyanine Green
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Invasive Ductal Carcinoma
Invasive Lobular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- Adult patients over 18 years of age
- 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).
- 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.
- Subject capable of giving informed consent and participating in the process of consent.
Exclusion
- 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)
- Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- Subjects with a history of iodide allergies
- At-risk patient populations
- Homeless patients
- Patients with drug or alcohol dependence
- Patients unable to participate in the consent process
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01796041
Start Date
July 1 2011
End Date
November 9 2016
Last Update
January 28 2021
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104