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Breast Neoplasms

Breast Diseases

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The radiotracer was injected with our modified injection technique (MIT) (periareolar intraparenchymal, high volume and ultrasonographic guidance). Internal mammary sentinel lymph node biopsy (IM-SLNB) was performed for patients with internal mammary visualized.

periareolar intraparenchymal, high volume and ultrasonographic guidance

IM-SLNB was performed for IMLN visualized patients

IM-SLNB

Yong-Sheng Wang, MD

Peng-Fei Qiu, MD

Yong-Sheng Yong-Sheng, MD

Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as "the first station" of lymphatic drainage in breast cancer, serving as an important reference for lymph staging and decision-making. Although the concept of Internal Mammary Sentinel Lymph Node Biopsy (IM-SLNB) has been included in the AJCC guidelines since the 6th edition, technical bottlenecks and clinical benefits still remained to be the main reasons limiting its clinical application:

Technical bottlenecks: In previous clinical practice, the internal mammary visualization rate was very low (13% on average, 0% -37%) under the guidance of the traditional radionuclide injection technique, which became a technology bottleneck restricting the widespread of IM-SLNB. After continuous exploration, our center invented the "modified injection technique" of injecting the nuclide tracer into the mammary gland layer at 6 and 12 o'clock around the areolar under the guidance of ultrasound, as well as increasing the injection volume to increase the local tension. A high internal mammary imaging rate of 71% was obtained, which laid a foundation for the further study and clinical application of IM-SLNB.

Clinical benefits: The IM-SLNB is a method to assess IMLN metastatic status in a minimally invasive way, which may improve the system of regional staging and guide precise IMLN treatment. However, based on the current IM-SLNB indication, the internal mammary metastasis rate was only 8%-15%, and it only had little influence on treatment strategy, which led to the controversy of its clinical application. Previous studies of extended radical mastectomy showed that in ALN positive patients the IMLN metastasis rate was 28-52%, while in ALN negative patients the metastasis rate was only 5-17%. Therefore, the continuation of the previous A-SLNB indication (clinical ALN negative) to IM-SLNB is apparently not in line with the current clinical practice, but further evaluation of internal mammary metastasis status in clinical ALN positive patients may receive greater benefit.

This prospective multicenter study attempted to perform IM-SLNB with our modified injection technique both in clinical ALN negative and positive patients for the first time. Through analyzing metastasis rate of IMLN as well as the influences it had on decision making, we hoped to develop more accurate indication for IM-SLNB and guide the individualized precise treatment of IMLN.

Tracer injection and Lymphatic imaging: The radionuclide tracer (99mTc-Sulfur colloid) was prepared by the Nuclear Medicine Department and the sulfur colloid kit (equipped with a filter of 220 nm in diameter to control the size of colloidal particles) was prepared by Beijing Xinkesida company. All patients were injected with 99mTc-Sulfur colloid (1.0\~1.2ml/29.6\~55.5MBq) in periareolar parenchyma gland under the guidance of ultrasound using the "new injection technique" 3-18h before surgery. SPECT / CT lymphoscintigraphy was performed 30 min before surgery, and the radioactive concentration ("hot spot") near the sternum was defined as IMSLN positive.

IM-SLNB: After modified radical mastectomy / breast-conserving radical surgery, intraoperative γ-detector (Neoprobe 2000, Johnson\& Johnson Company) was used to locate IM-SLN, and intercostal IM-SLNB was performed: open pectoralis major muscle, expose the parasternal intercostal space at the corresponding intercostal level (if the patient underwent breast-conserving surgery and the tumor was located in the lateral quadrant, an additional 3 cm of skin incision was required), cut the intercostal muscle at radioactive concentration site parallel to the rib, search and locate IMSLN with gamma detector, dissect precisely to avoid injury of internal mammary arteries and veins, and then sent the removed tissue to routine pathological examination.

Pathologic diagnosis: IMSLN was divided into 2mm tissue fragments according to the long axis (short diameter \< 2 mm, no division), every tissue fragment required one layer of routine HE staining pathological examination. In this study, metastasis \> 0.2mm was defined as IMSLN positive, while solitary tumor cell was defined as IMSLN negative. Further IHC detection of CK-9 was required if the IMSLN was HE staining negative to exclude micrometastasis.

Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique

A Prospective Multicenter Clinical Trial of Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique for Early Breast Cancer

The internal mammary sentinel lymph node visualization rate with our modified injection techniques

Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB

IM-SLNB complications in the patients who receive IM-SLNB

Metastasis rate of IMSLN in clinically axillary node-negative and clinically axillary node-positive patients

The Affiliated Hospital of Qingdao University

Henan Cancer Hospital

Shandong Cancer Hospital and Institute

Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor

conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.

modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.

Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5\~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: 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.

99mTc-labeled Sulfur Colloid

Axillary Sentinel Lymph Node Biopsy

Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery

Methylthioninium

Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).

Lymphoscintigraphy

ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.

Axillary Lymph Node Dissection

Internal mammary sentinel lymph node biopsy

Internal Mammary Sentinel Lymph Node Biopsy

Yong-sheng Wang, MD

Peng-fei Qiu, MD

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2\~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

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.

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

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

Visualization rate of IMSLN between conventional and modified techniques

Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique	NCT03541278	Breast Cancer	MIT IM-SLNB	18 Years - 70 Years	Shandong Cancer Hospital and Institute
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative	NCT01642511	Breast Cancer	99mTc-labeled S... Axillary Sentin... Methylthioniniu... Lymphoscintigra... Axillary Lymph ... Internal Mammar...	18 Years - 80 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for internal mammary sentinel lymph node biopsy