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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: IM-SLNB; Radiation: 99mTc-SC; Device: Histologic Examination; Device: LSG; Drug: Methylthioninium

• Registration Number: NCT01668914
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Study Start: 2014-02
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• primary breast cancer
• clinically axilla-positive

Exclusion Criteria

• enlarged internal mammary nodes by imaging

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clinically positive axillary nodes	IM-SLNB	3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
clinically positive axillary nodes	99mTc-SC	3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
clinically positive axillary nodes	Histologic Examination	3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
clinically positive axillary nodes	LSG	3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
clinically positive axillary nodes	Methylthioninium	3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination

Primary Outcome Measures

Name	Time	Method
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB	1 year	Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Secondary Outcome Measures

Name	Time	Method
Visualization Rate of IMSLNs	1 year	visualization rate of internal mammary hotspots in lymphoscintigraphy
Metastasis Rate of IMSLNs	1 year	Metastasis Rate of internal mammary sentinel lymph node

Trial Locations

Locations (1)

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China