Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

NCT02287675 | Completed Phase 4 Results

• 1 other identifier: KHNIC-P14-N001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Sentinel Node

Outcome Measures

Primary Outcomes (2)

• Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC).

  The rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.

  2 hours

• Sentinel Lymph Node Uptake Rate

  SLN uptake rates will be determined by planar SPECT (single-photon emission computerized tomography) imaging and by SPECT/CT (CT-computed tomography). Gamma counts will be obtained at the injection site by standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes. Figures showing the percent of peak activity in the node versus time will be constructed for each radiopharmaceutical. The average uptake rate for each radiopharmaceutical will be computed and the following test will be conducted using a two-sample t-test at a two-sided α=0.05 (one-sided α=0.025) level of significance: H0 (null hypothesis): µLS ≤ µSC vs. HA (alternative hypothesis): µLS \> µSC, (µLS is the average SLN uptake rate of Lymphoseek) (µSC is the average SLN uptake rate of 99mTc Sulfur Colloid).

  2 hours

Secondary Outcomes (4)

• Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified

  24 hours

• Ratio of Intraoperative Gamma Counts

  24 hours

• Patient Pain Tolerance

  24 hours

• Pathologic Assessment of the Excised Lymph Node(s)

  24 hours

Study Arms (2)

Lymphoseek

ACTIVE COMPARATOR

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.

Drug: Lymphoseek

Sulfur Colloid

ACTIVE COMPARATOR

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.

Drug: Sulfur Colloid

Interventions

Lymphoseek DRUG

Subjects will receive a single intradermal injection of Lymphoseek followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. Lymphoseek positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.

Also known as: technetium Tc 99m tilmanocept

Lymphoseek

Sulfur Colloid DRUG

Subjects will receive a single intradermal injection of 99mTc-SC followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. 99mTc-SC positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.

Also known as: 99mTc-SC, 99mTc-SC Sulfur Colloid

Sulfur Colloid

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kettering Health Network: lead

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Arash Kardan
• Organization: Kettering Health Network

arash.kardan@ketteringhealth.org

937-395-8611

Study Officials

• Arash Kardan, MD

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: January 19, 2015
• Primary Completion: January 23, 2017
• Study Completion: August 31, 2017
• Last Updated: July 28, 2020
• Results First Posted: January 9, 2019

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)