Sentinel Lymph Node Mapping With Superparamagnetic Iron Oxide for Melanoma: a Pilot Study in Healthy Participants to Establish an Optimal MRI Workflow Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- SPIO dosage in milliliters
研究概览
简要总结
Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc.
Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process.
Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants;
- •Participants should be ≥18 years of age at the time of consent;
- •Participants should be willing to provide informed consent.
排除标准
- •Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself;
- •Standard MRI exclusion criteria:
- •Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
- •Any other metal implants;
- •Claustrophobia;
- •MR-incompatible prosthetic heart valves;
- •Tattoos inked with metallic dye.
- •Participants who refuse to provide informed consent.
研究组 & 干预措施
Healthy participants
干预措施: Sentinel node mapping using MRI (Diagnostic Test)
结局指标
主要结局
SPIO dosage in milliliters
时间窗: Three weeks
SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Massage duration in seconds
时间窗: Three weeks
Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Time to artefact appearance in minutes
时间窗: Three weeks
Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
次要结局
未报告次要终点
研究者
James van Bastelaar
Head of department of Surgery (Surgical Oncologist)
Zuyderland Medisch Centrum