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

Breast Cancer Clinical Trial

— IMSLNB-CANP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668914
• Other study ID #: IMSN002
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2012
• Last updated: April 3, 2018
• Start date: February 2014
• Est. completion date: December 2017

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 nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

Description:

OBJECTIVES:

• Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.

• Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.

• Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• primary breast cancer

• clinically axilla-positive

Exclusion Criteria:

• enlarged internal mammary nodes by imaging

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• IM-SLNB
IM-SLNB is performed according to the pre-operative lymphoscintigraphy

Radiation:
• 99mTc-SC
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.

Device:
• Histologic Examination
All IMSLNs were analyzed by histologic examination for future therapy planning.
• LSG
lymphoscintigraphy was performed 0.5~1.0 hour before surgery

Drug:
• Methylthioninium
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB	Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB	1 year
Secondary	Visualization Rate of IMSLNs	visualization rate of internal mammary hotspots in lymphoscintigraphy	1 year
Secondary	Metastasis Rate of IMSLNs	Metastasis Rate of internal mammary sentinel lymph node	1 year