Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)

This study is currently recruiting participants.
Verified June 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01796041
First received: January 18, 2013
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Invasive Ductal Carcinoma
Invasive Lobular Carcinoma
Ductal Carcinoma
Drug: Indocyanine Green
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Identification [ Time Frame: After infusion of ICG ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Evaluation [ Time Frame: 0-5 years after surgery ] [ Designated as safety issue: No ]
    a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.

  • Evaluation [ Time Frame: 0-5 years after surgery ] [ Designated as safety issue: No ]
    b) evaluate the rate of re-excision in participants compared to a matched case- control cohort with similar clinicopathological characteristics undergoing breast conservation surgery.

  • Evaluation [ Time Frame: 0-5 years after surgery ] [ Designated as safety issue: No ]
    C) evaluate progression free survival in our study cohorts


Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Injection of ICG Drug: Indocyanine Green
Other Names:
  • ICG
  • The chemical formula is C45H47N2O6S2Na

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796041

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal       sunil.singhal@uphs.upenn.edu   
Principal Investigator: Sunil Singhal, M.D.         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Sunil Singhall, Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01796041     History of Changes
Other Study ID Numbers: UPCC 12111, 813695
Study First Received: January 18, 2013
Last Updated: June 28, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Breast Neoplasms
Carcinoma
Carcinoma, Lobular
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 17, 2014