Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer (Lymphoseek)

Kettering Health Network

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Sulfur Colloid; Drug: Lymphoseek

Study type: Interventional

Funder types: Other

Identifiers

NCT02287675

KHNIC-P14-N001

Details and patient eligibility

About

To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).

Full description

Single center, blinded, randomized, parallel-group, comparative study of Lymphoseek and 99mTc-SC in the preoperative and intraoperative detection of lymph nodes in subjects with known breast cancer. All subjects will receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 millicurie (mCi) Tc 99m or 0.5 mCi of 99mTc-SC. Subjects may also receive up to 1 mL of vital blue dye (VBD) as a companion ILM agent. All radio-labeled agents will be administered in a single intradermal injection.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must be female and 18 years of age or older.
• The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer
• The subject must have a diagnosis of primary breast cancer.
• The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.
• The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2
• The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study

Exclusion criteria

• The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.
• The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.
• The subject has a positive pregnancy test or is lactating.
• The subject has had prior surgery to the indicated breast or axilla.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Lymphoseek

Active Comparator group

Description:

Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.

Treatment:

Drug: Lymphoseek

Sulfur Colloid

Active Comparator group

Description:

Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows: In adults, to assist in the: * localization of lymph nodes draining a primary tumor in patients with * breast cancer or malignant melanoma when used with a hand-held gamma counter. * evaluation of peritoneovenous (LeVeen) shunt patency in adults.

Treatment:

Drug: Sulfur Colloid