Clinical trial NCT02287675: Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
Official title: A Randomized, Double-Blinded Trial Comparing Lymphoseek and 99mTc-Sulfur Colloid With Regard to Pre-op Imaging and Imaging Drug Kinetics and Intra-op Lymphatic Mapping and Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Sentinel Node
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC).
timeFrame: 2 hours
measure: Sentinel Lymph Node Uptake Rate
timeFrame: 2 hours
Secondary outcomes:
measure: Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified
timeFrame: 24 hours
measure: Ratio of Intraoperative Gamma Counts
timeFrame: 24 hours
measure: Patient Pain Tolerance
timeFrame: 24 hours
measure: Pathologic Assessment of the Excised Lymph Node(s)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Arash Kardan, MD
role: PRINCIPAL_INVESTIGATOR
References: