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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Yongsheng Wang, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01642511
First received: July 11, 2012
Last updated: August 24, 2013
Last verified: August 2013

July 11, 2012
August 24, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
Visualization rate of IMSLN [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Visualization rate of IMSLN between conventional and modified techniques
Same as current
Complete list of historical versions of study NCT01642511 on ClinicalTrials.gov Archive Site
  • Metastasis Rate of IMSLN [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB
  • Frequency and Severity of Complications with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Success rate of IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Radiation: 99mTc-labeled Sulfur Colloid
    Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant.
    Other Name: 99mTc-SC
  • Radiation: 99mTc-labeled Sulfur Colloid
    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
    Other Name: methylthioninium
  • 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
  • Active Comparator: Control Group
    conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant.
    Interventions:
    • 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
  • Experimental: Study Group
    modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast.
    Interventions:
    • 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
Qiu PF, Liu JJ, Liu YB, Yang GR, Sun X, Wang YS. A modified technology could significantly improve the visualization rate of the internal mammary sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2012 Nov;136(1):319-21. doi: 10.1007/s10549-012-2203-5. Epub 2012 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary breast cancer
  • clinically axilla-negative

Exclusion Criteria:

  • enlarged internal mammary nodes by imaging
Female
18 Years to 80 Years
No
Contact: Yong-sheng Wang, MD +8613505409989 wangysh2008@yahoo.com.cn
Contact: Peng-fei Qiu, MD +8615168872002 qiupengfei2002@yahoo.cn
China
 
NCT01642511
IMSN001
No
Yongsheng Wang, Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
Not Provided
Study Chair: Yong-sheng Wang, MD Shandong Cancer Hospital
Principal Investigator: Peng-fei Qiu, MD Shandong Cancer Hospital
Shandong Cancer Hospital and Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP