Intraoperative Imaging of Breast Cancer With Indocyanine Green

NCT01796041 | Completed Early Phase 1 DMC

• 2 other identifiers: UPCC 12111813695
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Invasive Ductal Carcinoma; Invasive Lobular Carcinoma; Ductal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation

  0-5 years after surgery

• Evaluation

  0-5 years after surgery

• Evaluation

  0-5 years after surgery

Study Arms (1)

IV Injection of ICG

EXPERIMENTAL

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Also known as: ICG, The chemical formula is C45H47N2O6S2Na

IV Injection of ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Lobular; Carcinoma, Ductal

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: February 21, 2013
• Study Start: July 1, 2011
• Primary Completion: November 9, 2016
• Study Completion: November 9, 2016
• Last Updated: January 28, 2021

Record last verified: 2018-02

Locations

US (1)