Use of Super Paramagnetic Iron Oxide (Magtrace) Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer - The MagBracket Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Success localization of bracketing Magtrace injection with Magnetic probe
研究概览
简要总结
Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy. Surgical adjuncts used in identifying and localizing the area for excision include metallic wire, radioactive or magnetic seeds and radiofrequency reflectors. These are placed in the lesion under image guidance by the breast radiologists, either on the day of surgery (wires) or prior (seeds). Bracketing localization is performed in case of multiple lesions or wide spread calcifications to aid the surgeons in performing wide local excision of all involved areas. This means placing multiple devices around the area of excision for accurate triangulation, which increase the costs significantly.
Localization agents like radionucleotide labelled albumin, super paramagnetic iron oxide (SPIO) and colored dyes like methylene blue, isosulphane blue and indocyanine green are injected in the breast for identification of sentinel lymph nodes in the axilla.
More recent studies have demonstrated successful use of SPIO in localization of small impalpable breast cancer lesions. This also raises the prospect of using SPIO for the dual purpose of lesion localization / bracketing and sentinel node biopsy. This study was designed to test this principle in patients requiring bracketing.
This is a prospective proof-of-concept pilot study to evaluate the feasibility of SPIO (Magtrace®) as a single-agent solution for bracketing the excision area and localizing the sentinel lymph node for breast-conserving surgery. Patients with breast cancer requiring bracketing and sentinel node biopsy will be identified through multidisciplinary breast tumor board and invited to take part in the study. All patients who consent to participate will receive an injection of Magtrace® for bracketing (0.5ml each at four points around the excision area) one day before surgery under ultrasound guidance. Primary outcome will be successful localization of the Magtrace® signal in breast for bracketing and in the sentinel node, using a magnetic probe on the day of surgery. Clinical outcomes, complications and cost analyses will be performed as secondary outcomes. We anticipate a sample size of 35 patients to be recruited for the study.
详细描述
Early-stage breast cancer is commonly managed with breast-conserving surgery (BCS) and sentinel lymph node biopsy (SLNB), aiming to minimize surgical morbidity while achieving optimal cosmetic results. Accurate preoperative or intraoperative localization of both the breast lesion and the sentinel lymph node is essential for complete tumor excision and accurate nodal staging.
Bracketed Localization of Breast Lesions Among the available localization methods, bracketed localization is used to delineate the boundaries of wide local excision in cases of extensive suspicious changes, calcifications, or multiple lesions related to invasive or in situ breast cancer. Historically, wire-guided localization (WGL) has been the standard for bracketed lesion localization; however, it can pose challenges such as wire displacement, patient discomfort, and variable success rates . In an effort to overcome these drawbacks, alternative approaches-such as radioactive seed localization and magnetic seed localization-have shown promising results.
Sentinel Lymph Node Localization and Dual-Tracer Approaches Sentinel lymph node biopsy remains a cornerstone in breast cancer staging and typically involves injecting a radioisotope and/or blue dye. Recently, superparamagnetic iron oxide (SPIO) tracers, such as Magtrace®, have emerged as an effective alternative, eliminating the need for handling radioactive materials. The Magnetic Sentinel Node and Occult Lesion Localization (MagSNOLL) framework has demonstrated the feasibility of leveraging magnetic tracers for both lesion and lymph node localization.
Although dual-tracer methods, where one agent targets the lesion and another identifies the sentinel lymph node, are well-established, using a single agent to perform both tasks has been less common in routine clinical practice. In many protocols that incorporate SPIO for sentinel node detection, separate localization tools (e.g., wires or radioactive seeds) are still employed for the primary lesion.
Rationale - Magtrace as a Dual Modality Magtrace® (SPIO) has consistently demonstrated safety and accuracy for sentinel lymph node localization. It is proposed that Magtrace® can also be utilized for bracketing the primary tumor, referred to here as bracketing Magnetic Tracer Localization (bMTL). By consolidating both bracketing and sentinel lymph node localization into a single modality, it may be possible to streamline the surgical process, reduce the number of procedures, and potentially improve patient experiences and outcomes.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- All patients with breast cancer undergoing breast conserving surgery requiring bracketing of the area of excision (as determined by the multidisciplinary tumor board) and a sentinel lymph node biopsy for axillary staging.
排除标准
- Patients having mastectomy.
- Patients unfit for breast conserving surgery due to inability to have adjuvant radiotherapy.
- Patients requiring axillary clearance without sentinel node biopsy.
- Patient undergoing breast conserving surgery without need for sentinel node biopsy.
- Patient with metastatic breast cancer requiring palliative surgery for local control.
- Patients not consenting for research.
- Patient with allergy to Magtrace.
研究组 & 干预措施
Magtrace Bracketing
Patients identified from breast multidisciplinary team meeting who require breast conserving surgery with bracketing required for the area of excision, with sentinel lymph node biopsy simultaneously will be recruited to the study (single intervention arm). Informed consent will be obtained for all patients who agree to take part in the study. Patients who agree to participate will receive Magtrace Injection in the breast one day before surgery. Magtrace will be injected at four points around the area to excised for bracketing.
干预措施: Super paramagnetic iron oxide bracketing injection (Other)
结局指标
主要结局
Success localization of bracketing Magtrace injection with Magnetic probe
时间窗: Morning of surgery.
A hand held magnetic localization probe (Sentimag) will be used on the morning of surgery by the operating surgeon to localize the signal of Magtrace at four points bracketed around the area of the breast to be excised. For the bracketing localization to be considered successful, signal localization will be required to be present at all four points.
次要结局
- Successful sentinel node localization with Magnetic probe(Time of surgery)
- Duration of surgery(Time of surgery)
- Breast tissue resection weight and volume(Time of surgery)
- Resection margin positivity rate (proportion of patient with tumor present at resection margin on final histology)(2 weeks post surgery.)
- Re-operation rates(3 months)
- Post operative complications (immediate and delayed)(3 months)
研究者
Fayyaz Mazari
Consultant Oncoplastic Breast & General Surgeon
研究点 (1)
标识符
- NCT 编号
- NCT07844473
- 其他研究编号
- IRB#2261285
日期
- 首次提交
- (上个月)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Study protocol and informed consent form will be be made available at the time of study registration. Anonymized patient data collected during the study along with the primary and secondary outcomes data used for analysis will be made available at the end of the study in accordance and compliance with the Institutional and National data protection laws.