A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy.
研究概览
简要总结
The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.
详细描述
When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. Currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. But physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. Neither assessment tool is optimal.
This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes.
In this study, patients with low risk melanoma will receive very high-resolution MRI scans of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the MRI.
Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the MRI results. Again, results from the biopsy will be compared to the results from the MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes.
We plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma involvement of regional lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision
- •eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed
- •adequate renal function (creatinine 2 or less)
- •life expectancy 2 years of more
排除标准
- •history of severe claustrophobia precluding MRI scans
- •known hypersensitivity or other contraindication to gadolinium contrast
- •known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)
结局指标
主要结局
Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Peter Brett, M.D.
Physician
Redwood Regional Medical Group