Intraoperative Imaging of Breast Cancer With Indocyanine Green

Invasive Ductal Carcinoma Clinical Trial

— ICG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796041
• Other study ID #: UPCC 12111
• Secondary ID: 813695
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2011
• Est. completion date: November 9, 2016

Study information

• Verified date: February 2018
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 9, 2016
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Lobular
• Ductal Carcinoma
• Invasive Ductal Carcinoma
• Invasive Lobular Carcinoma

Intervention

Drug:
• Indocyanine Green

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification	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)	After infusion of ICG
Secondary	Evaluation	a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.	0-5 years after surgery
Secondary	Evaluation	b) evaluate the rate of re-excision in participants compared to a matched case- control cohort with similar clinicopathological characteristics undergoing breast conservation surgery.	0-5 years after surgery
Secondary	Evaluation	C) evaluate progression free survival in our study cohorts	0-5 years after surgery