A Feasibility Study on the Timeframe of Superparamagnetic Iron Oxide Nanoparticles Administration in Patients Receiving Primary Systemic Therapy for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery
研究概览
简要总结
The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration.
For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST.
The main points to investigate are:
- If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
- If the nodal yield and the accuracy of the procedure are affected
详细描述
Superparamagnetic Iron Nanoparticles (SPIO) have shown comparable performance to the standard of Radioisotope (RI) +/- blue dye (BD) for Sentinel Lymph Node Detection in breast cancer, with the advantage of clinical convenience due to easier accessibility, disposal and injection days before surgery.
More interestingly, SPIO provides the possibility for delayed SLND in the setting of a preoperative diagnosis of DCIS, enabling SLN detection weeks after breast surgery, only when specimen pathology has demonstrated invasive cancer, as shown in the SentiNot study. The role of SPIO for SLND in the setting of primary systemic therapy (PST) has not been extensively investigated, while the timeframe from SPIO administration to successful SLN detection in a similar fashion to SentiNot, but in the setting of PST has yet to been defined.
Current evidence suggest that RI-based SLN detection is the accepted standard following PST, with RI-based dual mapping specifically recommended in cN+-to-ycN0 patients, when SLND or targeted axillary dissection (TAD) are performed, as the number of SLNs retrieved has been inversely linked to the false negative rate of the procedure.
Apart from the logistic benefits of SPIO administration prior to PST, an aspect of potential interest is the ability to map the axilla, before the fibrotic changes induced by chemotherapy and lymphatic remodelling occur, that are a concern, especially in the node-positive patients at presentation.
However, in this case, it is imperative to investigate that SPIO remains detectable after a prolonged period of administration and that it does not migrate to higher nodal echelons. While preliminary data suggested feasibility, the aim of this dedicated study was to investigate the width of timeframe of SPIO administration in patients undergoing PST and how SPIO-based detection and concordance to the RI are affected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with non-metastatic primary breast cancer and cN0/cN1 axilla, as defined by clinical examination and axillary ultrasound (with fine needle aspiration or core biopsy verification of metastasis) intended for PST (chemotherapy, targeted treatment or endocrine therapy) with a curative intention at diagnosis,
排除标准
- •Distant metastases at diagnosis
- •Inflammatory breast cancer
- •Tumor progression during PST for cN1 patients
- •ycN1 after completion of PST
- •surgery before the completion of PST for any reason (PST adverse effects, patient preference)
- •cN1-to-ycN0 patients that opted for ALND
结局指标
主要结局
Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery
时间窗: At surgery
This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.
Detection rate
时间窗: At surgery
The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.
Concordance
时间窗: At surgery
The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)
次要结局
- Nodal yield(At surgery)
- Nodal concordance(At surgery)
研究者
Andreas Karakatsanis
Associate Professor, MD, PhD
Uppsala University