Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Are there any artefacts visible when undergoing a CEM?
研究概览
简要总结
Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts.
Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy.
Study design: Prospective trial in an outpatient clinic setting.
Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial.
Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023.
Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients of 18 years and older.
- •Previously underwent sentinel lymph node biopsy using MagTrace®.
- •Undergoing standard follow-up for previous breast cancer
排除标准
- •Unable to comprehend the extend and implications of the study and sign for informed consent.
- •Standard MRI exclusion criteria:
- •Implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator);
- •Any other metal implants;
- •Claustrophobia;
- •MR-incompatible prosthetic heart valves.
- •Standard CEM exclusion criteria:
- •Breast implants.
结局指标
主要结局
Are there any artefacts visible when undergoing a CEM?
时间窗: One year after surgery
Visible artefacts on CEM
Are there any artefacts visible when undergoing an MRI?
时间窗: One year after surgery
Visible artefacts on MRI
次要结局
- Size of the possible artefact.(One year after surgery)
- The possibility to assess the imaging by a trained radiologist(One year after surgery)
研究者
Yvonne Vissers
Principal investigator
Zuyderland Medisch Centrum