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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Invasive Ductal Carcinoma, Invasive Lobular Carcinoma, Ductal Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Identification

Outcome Description:

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)

Outcome Time Frame:

24 hours after infusion of ICG

Safety Issue:

No

Authority:

United States: Data and Safety Monitoring Board

Study ID:

UPCC 12111

NCT ID:

NCT01796041

Start Date:

July 2011

Completion Date:

March 2014

Related Keywords:

  • Invasive Ductal Carcinoma
  • Invasive Lobular Carcinoma
  • Ductal Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Lobular
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104