Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01668914
Acronym
IMSLNB-CANP
Enrollment
126
Registered
2012-08-20
Start date
2014-02-28
Completion date
2017-12-31
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREIM-SLNB

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

RADIATION99mTc-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.

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

DEVICELSG

lymphoscintigraphy was performed 0.5\ 1.0 hour before surgery

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

Sponsors

Shandong Cancer Hospital and Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* primary breast cancer * clinically axilla-positive

Exclusion criteria

* enlarged internal mammary nodes by imaging

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB1 yearNumber of Participants Whose Lymph Node Staging was Changed with IM-SLNB

Secondary

MeasureTime frameDescription
Visualization Rate of IMSLNs1 yearvisualization rate of internal mammary hotspots in lymphoscintigraphy
Metastasis Rate of IMSLNs1 yearMetastasis Rate of internal mammary sentinel lymph node

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026