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

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ClinicalTrials.gov Identifier: NCT02287675
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Kettering Health Network

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Lymphoseek Drug: Sulfur Colloid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 19, 2015
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : August 31, 2017


Arm Intervention/treatment
Active Comparator: Lymphoseek
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
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.
Other Name: technetium Tc 99m tilmanocept

Active Comparator: Sulfur Colloid

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
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.
Other Names:
  • 99mTc-SC
  • 99mTc-SC Sulfur Colloid




Primary Outcome Measures :
  1. Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC). [ Time Frame: 2 hours ]
    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. Sentinel Lymph Node Uptake Rate [ Time Frame: 2 hours ]
    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).


Secondary Outcome Measures :
  1. Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified [ Time Frame: 24 hours ]
    To compare the number of intraoperatively detected SLNs identified by Lymphoseek and 99mTc-SC on an agent cohort basis

  2. Ratio of Intraoperative Gamma Counts [ Time Frame: 24 hours ]
    To compare differences in the ratio of intraoperative counts for Lymphoseek vs 99mTc-SC for the hottest harvested axillary Sentinel Lymph Node (SLN) relative to the primary intradermal injection site.

  3. Patient Pain Tolerance [ Time Frame: 24 hours ]
    To compare patient pain tolerance (i.e., patient's perceived level of discomfort) at the injection site for Lymphoseek vs 99mTc-SC using Wong-Baker pain rating scale of 0-10, where the higher the score, the higher the pain level.

  4. Pathologic Assessment of the Excised Lymph Node(s) [ Time Frame: 24 hours ]
    To compare pathologic assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases for Lymphoseek vs 99mTc-SC.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287675


Locations
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United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Kettering Health Network
Investigators
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Principal Investigator: Arash Kardan, MD Kettering Health Network
  Study Documents (Full-Text)

Documents provided by Kettering Health Network:

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Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT02287675     History of Changes
Other Study ID Numbers: KHNIC-P14-N001
First Posted: November 11, 2014    Key Record Dates
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kettering Health Network:
Sentinel Node

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Dextrans
Technetium Tc 99m Pentetate
Anticoagulants
Plasma Substitutes
Blood Substitutes
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals