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

Breast Cancer Clinical Trial

— IMSLNB-EBCP  

Official title:

Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642511
• Other study ID #: IMSN001
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2012
• Last updated: April 2, 2018
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary breast cancer

• clinically axilla-negative

Exclusion Criteria:

• enlarged internal mammary nodes by imaging

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Procedure:
• Axillary Sentinel Lymph Node Biopsy
Sentinel lymph node biopsy

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).

Procedure:
• Axillary Lymph Node Dissection
ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
• Internal Mammary Sentinel Lymph Node Biopsy
Internal mammary sentinel lymph node biopsy

Locations

Country	Name	City	State
China	Shandong Cancer Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization rate of IMSLN	Visualization rate of IMSLN between conventional and modified techniques	1 year
Secondary	Metastasis Rate of IMSLN	Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB	15 months
Secondary	Frequency and Severity of Complications with IM-SLNB	IM-SLNB complications in the patients who receive IM-SLNB	1 year
Secondary	Success rate of IM-SLNB	Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB	1 year