NCT07298083招募中不适用
DoD Award NF230020 Identification of Metabolic Markers and Statistical Prediction of MPNST for Rapid Diagnosis and Assessment of Surgical Margins
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn if a handheld Mass Spectrometry device (MasSpec Pen) can accurately distinguish between masses, neurofibroma, and normal tissue during surgery.
详细描述
Primary Objectives:
Aim 1. Determine the metabolite and lipid profiles of MPNST, neurofibroma, and nerve tissues
Aim 2. Validate the handheld mass spectrometry device (MSPen-Orbitrap system) for MPNST and neurofibroma diagnosis and for intraoperative surgical margin evaluation
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will enroll approximately 60 participants diagnosed with either MPNST or neurofibroma who are undergoing surgical resection of an MPNST or neurofibroma as part of their standard of care.
- •Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- •Recurrent or primary disease.
- •Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
- •English and non-English speaking patients.
排除标准
- •Adult patients with cognitive impairment requiring a legally authorized representative for consent.
- •Patients under age 1 and neonates.
- •Patients who are pregnant and undergoing surgery for MPNST are not eligible.
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (2)
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