| Objective:Sentinel Lymph Node Biopsy(Sentinel Lymph Node Biopsy,SLNB)has replaced the Axillary Lymph Node Dissection(ALND)become the standard of patients with clinical-negative Axillary Lymph Node(ALN).The accurate positioning of Sentinel Lymph Node(SLN)is essential to the accurate staging,prognosis and treatment for breast cancer patients.Currently,it is recommend that a combination of radioisotope and blue dye for breast cancer SLNB,which is in order to obtain a higher success rate(96%)and low false negative rate(7.3%).The using of nuclear tracer is limited in our country for the radioactive pollution and damage,no approval by China’s Food and Drug Administration,and no Nuclear medicine some hospitals.The blue dye is stilled regarded as the only tracer in few hospitals.The small particles are easily dispersed,and may cause low success rate and high false negative rate.And indocyanine green fluorescence(ICG)is becoming a hot spot as SLNB tracer due to its characteristic of near infrared fluorescence spectrum.However,its smaller particles also make the second and third lymph node imaging,and its limited penetration distance is the obstacle of the related research.In our study,it is tried that different doses of CG-rituximab were injected.The main objective of our study is to develop the features of the new tracer,establish a new type of breast cancer targeted fluorescent tracer theory and technology system,and prompt the new tracer technology widely used in SLNB minimally invasive diagnosis in order to making more early breast cancer patients benefit from SLNB.Methods:From June 2015 to October 2016,we recruited 150 patients from Shandong cancer hospital that who are diagnosed T1-T2 invasive breast cancer by biopsy with clinically negative axilla.The mean age of the patients was 51 years(28~73).We divided the patients into two groups: group A(n=50),who were injected the new tracer 30 min before the operation;and group B(n=50),the ICG-rituximab was injected 16 hour before the operation.Then,the two group were injected into three sites(peritumoral,intratumoral,or subtumoral).99mTc-labeled sulfur colloid was injected under the ultrasonographic at 6o’clock and 12 o’clock for all patients.Then,different doses of ICG-rituximab in the ratio of 4:1 mixed were injected before surgery(group1 125 ug: 500 ug,group2 93.75 ug: 375 ug;group C 62.5 ug: 250 ug,group 4 25 ug: 100 ug;group 12.5 ug: 50 u g).SLNs were removed by direct visualization of blue lymphatic and a hand held gamma probe.And all removed lymph nodes were visualized using a MDM-I fluorescence imaging system(MDM),which is a near infrared imaging system.We divided all the SLNs at least 2 levels and permanent H&E stained slides were taken for each level.The metastatic deposits were classified as according to the criterion of the 7th edition of the American Joint Committee on Cancer.The adjuvant systemic therapy is determined by the treating physician according to the most recent National Comprehensive Cancer Network Clinical Practice Guidelines and St Gallen Consensus.The successful rate and complication of IM-SLNB and its impact on the systemic and locoregional treatment plan would be analyzed.Results:1.The success rate of radioactive isotope and blue dye were 100%.And 290 SLN were harvested.26 cases of SLNS were identified metastasis,there are other axillary lymph node metastasis in 6 cases at the same time,and 20 cases of SLN metastasized independently.A total of 39 SLN were metastasized,in which 84.6%(33/39)were ICG-rituximab fluorescence imaging.1 SLN identified false negative.The coincidence rate with radioactive isotope and blue dye was 86.2%,(258/290),accuracy was 99.6%(257/258),the sensitivity was 96.7%(33/34),Specificity 100%(225/225),the false negative rate was 2.9%(1/34).2.The climbing experiment suggest that the SLNS ICG-rituximab fluorescence imaging detected rate is reduced with the dose of the tracer,that are 91.7%,76.7%,67.7%,76.7% and 7.4% in each group(P < 0.05),and the non Sentinel Lymph Node(n-SLNS)imaging rate was 54.1%,6.7%,.3%,0%,0%.Conclusions:1.As a tracer for breast cancer,the consistency,accuracy and sensitivity of ICG – rituximab is equal to the 99mTc-labeled sulfur colloid and blue dye.2.High doses of ICG-rituximab easily cause secondary lymph node imaging,reducing sensitivity.Appropriate dose can ensure high accuracy and low false negative rate,providing accurate clinical stage for breast cancer patients.And the optimal injection time and dose are 3~18h before the operation and 93.75μg ICG with 375μg rituximab3.The false negative rate and the accuracy of ICG-rituximab tracer have nothing to do with the patient’s tumor location,disease stage and histological classification.4.ICG-rituximab is an accurate target of IM-SLN,which is of clinical significance for the application of IM-SLNB.5.The new fluorescent tracer ICG-rituximab breast cancer in SLNB,are visible and targeted to lymph node,that can avoid the diffusion of the small molecules such as blue dye and the pollution of radioactive isotope.Therefore,it is more easily accepted by all.Volunteer. |
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