MedTrace Logo

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

NCT01668914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-04-05

No results posted yet for this study

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.

Conditions

Interventions

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.

DEVICE

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

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Yong-sheng Wang, MD · Shandong Cancer Hospital and Institute

  • Peng-fei Qiu, MD · Shandong Cancer Hospital and Institute

  • Yan-bing Liu, MD · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668914 on ClinicalTrials.gov