NCT01296139已完成1 期
Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Optimal dose of Ferumoxytol for enhancing lymph nodes
研究概览
简要总结
Background:
- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer.
Objectives:
- To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have surgery to remove the prostate and surrounding lymph nodes.
Design:
- Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies.
- Participants will have a magnetic resonance imaging (MRI) scan to provide baseline images for the study.
- Participants will receive an injection of Ferumoxytol and will return for another MRI scan on the following day (around 24 hours later).
- Some participants may have a third MRI scan 48 hours after the initial injection of Ferumoxytol. This third MRI scan is optional and not required by the study.
- Although the scanning and followup portion of the study will last only a few days, participants will be considered to be enrolled on the study until after the prostate removal surgery.
详细描述
Background:
- Prostate cancer is the most common non-cutaneous malignancy among men in Western world. Accurate lymph node staging is important in treatment planning for prostate cancer.
- Conventional imaging modalities (e.g. computed tomography [CT] and magnetic resonance imaging [MRI]) are used for the evaluation of lymph node involvement in many cancer types, including prostate cancer, however diagnosis is based on node enlargement which is neither sensitive nor specific in prostate cancer.
- As a consequence, the standard of care is to remove numerous lymph nodes during prostatectomy to ascertain lymph node status.
- A prior imaging agent for detecting lymph node involvement, dextran coated ultrasmall superparamagnetic iron oxide particles (USPIO), also known as Ferumoxtran-10 (Combidex , AMAG Pharmaceuticals, Inc. Lexington, MA, US) was shown to localize lymph node metastases with much greater accuracy than unenhanced MRI. Although a large study in lymph node imaging in prostate cancer was successfully conducted using ferumoxtran-10, the FDA Advisory Panel did not recommend broad use approval of this agent.
- A derivative of ferumoxtran-10, Ferumoxytol (Feraheme AMAG Pharmaceuticals, Inc. Lexington, MA, US) has been approved for iron replacement therapy. It is a semisynthetic carbohydrate coated, magnetic iron oxide preparation. This compound is taken up by normal lymph nodes, excluded from malignant nodal tissue. A single study of Ferumoxytol enhanced MRI demonstrated some efficacy of this agent at 24 hours but only one dose was used, MRI at later time points was not performed.
- Initial results of the NCI trial (11-C-0098) revealed that using the dose of 7.5 mg/kg Fe is safe and it yields a more homogenous and accurate signal changes in benign lymph nodes in comparison with the 4 and 6 mg/kg Fe doses. However, utility of this initial result could not be validated in depiction of signal change difference between benign and malignant lymph nodes with prostate cancer metastases.
Primary Objective
-To determine the optimal dose of Ferumoxytol for enhancing lymph nodes in patients with prostate cancer.
Eligibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
All subjects will receive 7.5 mg/kg Fe
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Optimal dose of Ferumoxytol for enhancing lymph nodes
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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