Cleveland, Ohio 44195


Purpose:

This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure. Patients will undergo lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to planned next morning surgery or on the morning of surgery. Patients will undergo lymphoscintigraphy in accordance with standard clinical practice. Immediately prior to operation, after the induction of anesthesia in the operating room, up to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the tumor or into the subareolar region after disinfection of the breast skin. ICG movement will be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made evident by the fluorescent dye, will be monitored in real time on a monitor. The fluorescence will be followed towards the armpit region (axilla) and time for the fluorescence to reach the axilla will be recorded. Following standard practice, an incision will be made in the armpit region. Fluorescent lymph nodes (ICG positive) will be localized and removed and analyzed by a pathologist. Node removal will continue until no residual fluorescence is visible in the axilla. Removed nodes will be tested for radioactivity using a standard gamma-detecting probe and the counts per minute will be recorded. Finally, the armpit region will be inspected with the gamma probe to determine if there are any residual radioactive nodes. Residual sentinel nodes (the first node to receive lymph from a tumor) will be removed. For the purposes of this study, the sentinel status of a node will be defined as being flagged as sentinel by either one or both of the ICG or 99mTc methods. The goal of the project is to confirm that axillary lymphatic mapping with ICG leads to similar nodes being labeled as sentinel as lymphatic mapping with 99mTc-labeled radiotracer.


Study summary:

PRIMARY OBJECTIVES: I. To confirm that axillary lymphatic mapping with indocyanine green solution (ICG) solution leads to a similar number of nodes being labeled as sentinel as lymphatic mapping with 99mTc-labeled (technetium Tc-99m sulfur colloid) radiotracer. OUTLINE: Patients receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, patients also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Patients then undergo axillary sentinel node biopsy and surgery.


Criteria:

Inclusion Criteria: - Patients with a confirmed diagnosis of clinical stage 1 or 2 breast cancer - Patients who are undergoing breast cancer surgery with lumpectomy or mastectomy - Patients with planned axillary sentinel node biopsy procedure Exclusion Criteria: - Patients with cancer > 3 cm - Patients with clinically positive nodes - Patients with prior surgery for breast cancer in the index breast - Patiens who have had bilateral breast surgeries - Thyroid dysfunction - Hypersensitivity to iodine - Hepatic insufficiency - Renal insufficiency


NCT ID:

NCT02419807


Primary Contact:

Principal Investigator
Stephen Grobmyer, MD
Case Comprehensive Cancer Center

Stephen Grobmyer, MD
Phone: 216-636-2843
Email: grobmys@ccf.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States

Stephen Grobmyer, MD
Phone: 216-636-2843
Email: grobmys@ccf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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