Ferumoxytol-Enhanced Magnetic Resonance Imaging (MRI) in Pediatric and Adult Patients With Malignant Sarcoma: A Two-part Pilot Study for Safety and Efficacy in the Pediatric and Adult Populations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Feasibility and sensitivity of nanoparticle-enhanced MRI
研究概览
简要总结
This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast agent is an investigational drug. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved ferumoxytol for this use. This drug has been used to image adults with other forms of cancer, however, it has only been used to image a small number of pediatric patients. Ferumoxytol has never been used to image sarcoma.
详细描述
Before the research starts you will undergo some screening procedures to confirm that you are eligible to participate in the study. These include a medical history, blood tests and an electrocardiogram.
After we confirm taht you are eligible for this study you will undergo the following. We estimate that you will be on the study for approximately two to three weeks.
Baseline MRI of the tumor site and draining lymph nodes: Whether you are on the study or not you will have a baseline MRI which involves the use of a standard contrast agent called gadolinium. This imaging test is considered the standard of care and is the method by which doctors determine tumor location and spread. This MRI is NOT part of the study.
Ferumoxytol Infusion: You will receive this study drug the same day as your baseline MRI; if you already had your baseline MRI, this medication can be given intravenously (i.e. directly into the vein) at your next clinical visit. It can likewise be given through a central line. You will be observed during the infusion and 30 minutes after the infusion to ensure that you do not have an allergic or adverse reaction to the medication.
Repeat MRI of the tumor site and draining lymph nodes: Three to five days after receiving ferumoxytol, you will undergo a repeat MRI. You will not require any additional contrast prior to this imaging study. This MRI is part of the study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of soft tissue sarcoma, who will undergo lymph node biopsy
- •Able to tolerate MRI scan without sedation/anesthesia
- •Greater than or equal to 12 years of age
排除标准
- •Previous therapy other than biopsy or surgical resection of the primary tumor
- •Pregnant or breastfeeding
- •Receipt of other iron-oxide based nanoparticle therapy within 4 weeks of scans
- •History of allergic reaction to compounds of similar composition to ferumoxytol
- •Known diagnosis of hemochromatosis, mitochondrial disorder or iron overload
- •Invasive bacterial infection
- •Known history of contrast sensitivity
- •Braces or metal heart valve that may interfere with MRI, surgical clips, a pacemaker, piercings that cannot be removed, or any other indwelling metal device that might interfere with MRI
研究组 & 干预措施
Nanoparticle enhanced MRI
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Feasibility and sensitivity of nanoparticle-enhanced MRI
时间窗: 4 years
To determine the feasibility and evaluate the sensitivity of using nanoparticle-enhanced MRI in detecting lymph node metastases in pediatric and adult soft tissue sarcoma patients with clinically palpable or radiographically concerning lymph nodes, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard
Sensitivity of nanoparticle-enhanced MRI in occult lymph node metastases
时间窗: 4 years
To evaluate the sensitivity of nanoparticle-enhanced MRI in detecting occult lymph node metastases in pediatric and adult patients with soft tissue sarcoma, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard
次要结局
- Sensitivity of conventional MRI vs. nanoparticle enhanced MRI(4 years)
- Compare inter-reader variability in the interpretation of nanoparticle MRI scans(4 years)
- Retrospective central pathology review(4 years)
- Safety of ferumoxytol in pediatric patients(4 years)
研究者
Allison O'Neill
Principal Investigator
Dana-Farber Cancer Institute