A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
研究概览
简要总结
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2*-weighted sequences to improve the accuracy of nodal staging.
详细描述
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast. Superparamagnetic iron oxide (SPIO) particles, such as MPB-2043, have shown promise as MRI contrast agents, particularly in the detection of metastatic lesions in the liver. This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes.
In this study, T1/T2/T2*-weighted MRI sequences will be used to assess signal intensity (SI) changes in lymph nodes after the administration of MPB-2043. The susceptibility effects of the iron oxide core cause tissue signal loss, which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system, allowing for differentiation from malignant lymph nodes. The study will evaluate the safety and effectiveness of four different doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging.
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes. The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 20 years and above
- •Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery
- •Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.
- •Subjects must be nonlactating.
- •Subjects must be able to understand and be willing to sign a written informed consent document.
- •Subjects must be able to comply with the study protocol.
排除标准
- •Subjects with contraindications to MRI
- •Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).
- •Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- •Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- •Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
- •Subjects with kidney disease or impairment.
- •Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.
- •Subjects with active hepatitis B or hepatitis C infection.
- •Subjects with bone marrow disorders or a history of a bone marrow transplant.
研究组 & 干预措施
Dose cohort 1
pre- and post-enhanced MRI
干预措施: MPB-2043 of 0.5 mg/kg (Drug)
Dose cohort 2
pre- and post-enhanced MRI
干预措施: MPB-2043 of 1.0 mg/kg (Drug)
Dose cohort 3
pre- and post-enhanced MRI
干预措施: MPB-2043 of 2.0 mg/kg (Drug)
Dose cohort 4
pre- and post-enhanced MRI
干预措施: MPB-2043 of 3.0 mg/kg (Drug)
结局指标
主要结局
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
时间窗: Measured at pre-injection (Baseline) and 24 hours post-injection.
1. Sensitivity is the proportion of true positive lymph nodes (those confirmed as metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change of 20% on T2\*-weighted sequences post-injection is considered indicative of metastasis. 2. Specificity is the proportion of true negative lymph nodes (those confirmed as non-metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change ≥ 50% on T2\*-weighted sequences post-injection is considered indicative of non-metastasis.
次要结局
- Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI(From baseline to 10 minutes post-injection, and 24 hours post-injection.)
- Number and Size of Lymph Nodes Detected in Head and Neck(Measured at pre-injection (Baseline) and 24 hours post-injection.)
- Determination of Optimal MPB-2043 Dosage for Lymph Node Imaging in Head and Neck MRI(Measured at pre-injection (Baseline) and 24 hours post-injection.)
- Safety Variables of Adverse Events(From baseline to Day 28 post-MPB-2043 administration.)
- Safety Variables of Clinical Laboratory Tests(From baseline to Day 28 post-MPB-2043 administration.)