Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)

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.

Study Overview

• Status: Completed
• Conditions: Invasive Ductal Carcinoma; Invasive Lobular Carcinoma; Ductal Carcinoma
• Intervention / Treatment: Drug: Indocyanine Green

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Injection of ICG	Drug: Indocyanine Green; Other Names: ICG; The chemical formula is C45H47N2O6S2Na

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation	a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.	0-5 years after surgery
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
Evaluation	C) evaluate progression free survival in our study cohorts	0-5 years after surgery

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 9, 2016
• Study Completion (Actual): November 9, 2016

Study Registration Dates

• First Submitted: January 18, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma; Carcinoma, Ductal; Carcinoma, Lobular
• Other Study ID Numbers: UPCC 12111; 813695 (Other Identifier: UPenn IRB Protocol #)