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


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 -Negative


OBJECTIVES:

- Compare the visualization rate of internal mammary sentinel lymph node in breast cancer
patients with different injection technologies.

- Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with
clinically axillary node -negative in these patients.

- Evaluate the risk factors for internal mammary sentinel lymph node metastasis

- Evaluate the success rate and the safety of internal mammary sentinel lymph node
biopsy.

- Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic
guidance in different patterns and injection methods were classified according to the number
of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before
surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were
identified by combining the use of intraoperative gamma detector and blue dye. The sentinel
lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and
immunohistochemistry for future therapy planning.


Inclusion Criteria:



- primary breast cancer

- clinically axilla-negative

Exclusion Criteria:

- enlarged internal mammary nodes by imaging

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visualization rate of IMSLN

Outcome Description:

Visualization rate of IMSLN between conventional and modified techniques

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:

IMSN001

NCT ID:

NCT01642511

Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Sentinel Lymph Node Biopsy
  • Internal Mammary
  • Lymphoscintigraphy
  • Breast Neoplasms

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