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临床试验/NCT01016938
NCT01016938已完成不适用

Dynamic MRI for Lung Tumor Motion and Lung Function

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors

研究概览

简要总结

Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.

Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.

The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.

The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.

In this study the participant will undergo a series of MRI scans with and without contrast dye.

This study is being funded through grants from the National Institutes of Health (NIH).

详细描述

In this protocol, we seek to assess whether tumor motion can be inferred using dynamic MRI and external surrogates. We propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic MRI and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic MRI with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years old or older
  • Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.

排除标准

  • Pregnant or breast-feeding women are excluded. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (IUDs), contraceptive implants under skin or contraceptive injections and condoms with foam.
  • Patients with kidney disease of any severity or on hemodialysis.
  • Patients who have metallic dental fillings or other metallic implants.
  • Patients with known allergies to gadolinium-based contrast agents.
  • Patients who have difficulty lying flat on their back for extended periods of time will be excluded

结局指标

主要结局

Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors

时间窗: 2 years

Tumor tracking using cine-MRI and external surrogates with an accuracy of \~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI.

次要结局

  • Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Department of Radiation Oncology

Principal Investigator

University of Maryland, Baltimore

研究点 (1)

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