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

NCT01668914 | Completed Phase 3

• 1 other identifier: IMSN002
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Clinically Axillary Node -Positive; Sentinel Lymph Node Biopsy; Internal Mammary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visualization Rate of IMSLNs

  1 year

• Metastasis Rate of IMSLNs

  1 year

Study Arms (1)

clinically positive axillary nodes

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

Procedure: IM-SLNB; Radiation: 99mTc-SC; Device: Histologic Examination; Device: LSG; Drug: Methylthioninium

Interventions

IM-SLNB PROCEDURE

IM-SLNB is performed according to the pre-operative lymphoscintigraphy

Also known as: Internal Mammary Sentinel Lymph Node Biopsy

clinically positive axillary nodes

99mTc-SC RADIATION

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.

Also known as: 99mTc-labeled Sulfur Colloid

clinically positive axillary nodes

Histologic Examination DEVICE

All IMSLNs were analyzed by histologic examination for future therapy planning.

Also known as: hematoxylin-eosin staining and immunohistochemistry

clinically positive axillary nodes

LSG DEVICE

lymphoscintigraphy was performed 0.5\~1.0 hour before surgery

Also known as: Lymphoscintigraphy

clinically positive axillary nodes

Methylthioninium DRUG

Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

clinically positive axillary nodes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary breast cancer
• clinically axilla-positive

You may not qualify if:

• enlarged internal mammary nodes by imaging

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Histological Techniques; Immunohistochemistry; Lymphoscintigraphy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Histocytochemistry; Cytological Techniques; Immunologic Techniques; Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Yong-sheng Wang, MD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

• Peng-fei Qiu, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• Yan-bing Liu, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: February 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CN (1)