Completed

IMSLNB-CANPInternal Mammary Sentinel Lymph Node Biopsy Impact on Treatment Plan in Clinically Axillary Node-Positive Breast Cancer Patients

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Study Aim

This study aims to evaluate how Internal Mammary Sentinel Lymph Node Biopsy (IM-SLNB) impacts the treatment plan for breast cancer patients who are clinically axillary node-positive, by observing changes in lymph node staging.

What is being tested

IM-SLNB: A Surgical Procedure

+ Breast Radiation with 99mTc-SC

+ Analyzing Lymph Nodes for Therapy

ProcedureRadiationDeviceDrug
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 18 to 70 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: February 2014
See protocol details

Summary

Principal SponsorShandong Cancer Hospital and Institute
Last updated: April 5, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2014

Actual date on which the first participant was enrolled.

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.

NCT01668914
Principal SponsorShandong Cancer Hospital and Institute
Last updated: April 5, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

2 inclusion criteria required to participate
clinically axilla-positive
primary breast cancer
1 exclusion criteria prevent from participating
enlarged internal mammary nodes by imaging

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Shandong Cancer Hospital

Jinan, ChinaOpen Shandong Cancer Hospital in Google Maps
CompletedOne Study Center