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