Magnetic-Guided Axillary UltraSound (MagUS) Sentinel Lymph Node Biopsy and Mapping in Patients with Early Breast Cancer. A Phase 2, Single-Arm Prospective Clinical Trial
Abstract:Lymph Node Dissection (SLND) is standard of care for diagnosing sentinel lymph node (SLN) status in patients with early breast cancer. Study aim was to determine whether the combination of Superparamagnetic iron oxide nanoparticles (SPIO) MRI-lymphography (MRI-LG) and a Magnetic-guided Axillary UltraSound (MagUS) with biopsy can allow for minimally invasive, axillary evaluation to de-escalate surgery. Patients were injected with 2 mL of SPIO and underwent MRI-LG for SN mapping. Thereafter MagUS and core needle… Show more
“…This study also looked at the timing of the injection and found that SPIO injections performed at a median of 16 days prior to SLND obtained a better identification rate ( p = 0.031) and higher lymph node retrieval rate ( p < 0.001) compared to injections on the morning of surgery. Other studies also suggested feasibility of preoperative injection up to weeks or months prior to surgery [ 22 , 23 , 29 ]. Although this study had been designed before these publications and examined preoperative injection up to 24 h, a longer waiting period might further reduce required injection volume of magnetic particles.…”
Section: Discussionmentioning
confidence: 99%
“…Preoperative injection more than one day, up to months, prior to surgery needs to be investigated in the future as well, to see if a longer waiting period facilitates more accumulation of iron in the SLNs and/or leads to complicating accumulation in secondary and tertiary nodes. In a recent study, patients were injected with SPIO prior to neoadjuvant chemotherapy, and MRI lymphography was compared before and after chemotherapy with a median of 130 days interval [ 29 ]. As a result, SPIO accumulation was observed in the same lymph nodes.…”
The magnetic technique, consisting of a magnetic tracer and a handheld magnetometer, is a promising alternative technique for sentinel lymph node dissection (SLND) and was shown to be non-inferior to the standard technique in terms of identification rates. In this study, injection characteristics (iron dose, dilution, time course and massaging) were evaluated to optimize magnetic tracer uptake in the sentinel lymph nodes (SLN) in a rat hindleg model. 202 successful SLNDs were performed. Iron uptake in the SLN is proportional (10% utilization rate) to the injection dose between 20 and 200 μg, showing a plateau uptake of 80 μg in the SLN around 1000 μg injection. Linear regression showed that time had a higher impact than dilution, on the SLN iron uptake. Massaging showed no significant change in iron uptake. The amount of residual iron at the injection site was also proportional to the injection dose without any plateau. Time was a significant factor for wash-out of residual iron. From these results, preoperative injection may be advantageous for SLN detection as well as reduction in residual iron at the injection site by potential decrease in required injection dose.
“…This study also looked at the timing of the injection and found that SPIO injections performed at a median of 16 days prior to SLND obtained a better identification rate ( p = 0.031) and higher lymph node retrieval rate ( p < 0.001) compared to injections on the morning of surgery. Other studies also suggested feasibility of preoperative injection up to weeks or months prior to surgery [ 22 , 23 , 29 ]. Although this study had been designed before these publications and examined preoperative injection up to 24 h, a longer waiting period might further reduce required injection volume of magnetic particles.…”
Section: Discussionmentioning
confidence: 99%
“…Preoperative injection more than one day, up to months, prior to surgery needs to be investigated in the future as well, to see if a longer waiting period facilitates more accumulation of iron in the SLNs and/or leads to complicating accumulation in secondary and tertiary nodes. In a recent study, patients were injected with SPIO prior to neoadjuvant chemotherapy, and MRI lymphography was compared before and after chemotherapy with a median of 130 days interval [ 29 ]. As a result, SPIO accumulation was observed in the same lymph nodes.…”
The magnetic technique, consisting of a magnetic tracer and a handheld magnetometer, is a promising alternative technique for sentinel lymph node dissection (SLND) and was shown to be non-inferior to the standard technique in terms of identification rates. In this study, injection characteristics (iron dose, dilution, time course and massaging) were evaluated to optimize magnetic tracer uptake in the sentinel lymph nodes (SLN) in a rat hindleg model. 202 successful SLNDs were performed. Iron uptake in the SLN is proportional (10% utilization rate) to the injection dose between 20 and 200 μg, showing a plateau uptake of 80 μg in the SLN around 1000 μg injection. Linear regression showed that time had a higher impact than dilution, on the SLN iron uptake. Massaging showed no significant change in iron uptake. The amount of residual iron at the injection site was also proportional to the injection dose without any plateau. Time was a significant factor for wash-out of residual iron. From these results, preoperative injection may be advantageous for SLN detection as well as reduction in residual iron at the injection site by potential decrease in required injection dose.
“… 19 The SLN nodules turned brown or black, and the MRI signal increased (Figure 3 ). 20 On SPIO‐enhanced MRI, metastatic positive SLN showed high‐signal‐intensity area, and negative SLN showed low signal intensity. Studies have shown that the sensitivity, specificity and accuracy of SPIO‐enhanced MRI at 1.5 T with fat‐suppressionsequence in diagnosing SLN metastasis are 100%, 96%, and 96%, respectively.…”
Section: Magnetic Tracer Methodsmentioning
confidence: 99%
“…(A) SLN before injection. (B) SLN enhanced after injection of SPIO (red circle). Source : Reference [20]. Copyright permission obtained…”
Sentinel lymph node biopsy has been regarded as the standard procedure for early staging breast cancer. One of the key steps is to locate the sentinel lymph node (SLN). The recommended method is the joint use of blue dye and radioisotope. However, due to radionuclide radiation and high cost, it is urgent to develop more convenient and sensitive imaging methods to accurately locate SLN. This article discusses the advancement of accurately locating SLN by isotope tracer imaging, magnetic tracer method, computed tomographic lymphography, and trans‐lymphatic contrast‐enhanced ultrasound, as well as proposing new propose for clinical diagnosis.
Cancer is one of the main causes of death worldwide. To date, and despite the advances in conventional treatment options, therapy in cancer is still far from optimal due to the non-specific systemic biodistribution of antitumor agents. The inadequate drug concentrations at the tumor site led to an increased incidence of multiple drug resistance and the appearance of many severe undesirable side effects. Nanotechnology, through the development of nanoscale-based pharmaceuticals, has emerged to provide new and innovative drugs to overcome these limitations. In this review, we provide an overview of the approved nanomedicine for cancer treatment and the rationale behind their designs and applications. We also highlight the new approaches that are currently under investigation and the perspectives and challenges for nanopharmaceuticals, focusing on the tumor microenvironment and tumor disseminate cells as the most attractive and effective strategies for cancer treatments.
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