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


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


Inclusion Criteria:



- primary breast cancer

- clinically axilla-positive

Exclusion Criteria:

- enlarged internal mammary nodes by imaging

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Yong-sheng Wang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Shandong Cancer Hospital

Authority:

China: Ministry of Health

Study ID:

IMSN002

NCT ID:

NCT01668914

Start Date:

August 2012

Completion Date:

December 2014

Related Keywords:

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

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