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Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative (IMSLNB-EBCP)

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ClinicalTrials.gov Identifier: NCT01642511
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute

Brief Summary:
In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: 99mTc-labeled Sulfur Colloid Procedure: Axillary Sentinel Lymph Node Biopsy Drug: Methylthioninium Device: Lymphoscintigraphy Procedure: Axillary Lymph Node Dissection Procedure: Internal Mammary Sentinel Lymph Node Biopsy Phase 2

Detailed Description:

OBJECTIVES:

  • Compare the visualization rate of internal mammary sentinel lymph node in breast cancer patients with different injection technologies.
  • Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node -negative in these patients.
  • Evaluate the risk factors for internal mammary sentinel lymph node metastasis
  • Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.
  • Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic guidance in different patterns and injection methods were classified according to the number of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were identified by combining the use of intraoperative gamma detector and blue dye. The sentinel lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and immunohistochemistry for future therapy planning.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Actual Study Start Date : January 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control Group
conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
Radiation: 99mTc-labeled Sulfur Colloid
Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
Other Name: 99mTc-SC
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Name: SLNB
Drug: Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Device: Lymphoscintigraphy
Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).
Other Name: LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Name: ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Name: IM-SLNB
Experimental: Study Group
modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
Procedure: Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy
Other Name: SLNB
Drug: Methylthioninium
Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
Device: Lymphoscintigraphy
Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).
Other Name: LSG
Procedure: Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
Other Name: ALND
Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy
Other Name: IM-SLNB



Primary Outcome Measures :
  1. Visualization rate of IMSLN [ Time Frame: 1 year ]
    Visualization rate of IMSLN between conventional and modified techniques


Secondary Outcome Measures :
  1. Metastasis Rate of IMSLN [ Time Frame: 15 months ]
    Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB

  2. Frequency and Severity of Complications with IM-SLNB [ Time Frame: 1 year ]
    IM-SLNB complications in the patients who receive IM-SLNB

  3. Success rate of IM-SLNB [ Time Frame: 1 year ]
    Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-negative

Exclusion Criteria:

  • enlarged internal mammary nodes by imaging

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): NCT01642511


Locations
China, Shandong
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Study Chair: Yong-sheng Wang, MD Shandong Cancer Hospital
Principal Investigator: Peng-fei Qiu, MD Shandong Cancer Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yongsheng Wang, Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01642511     History of Changes
Other Study ID Numbers: IMSN001
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Yongsheng Wang, Shandong Cancer Hospital and Institute:
Breast Cancer
Sentinel Lymph Node Biopsy
Internal Mammary
Lymphoscintigraphy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases