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A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

2019年5月7日 更新者:National Cancer Institute (NCI)

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.

This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

研究概览

地位

完全的

详细说明

Background:

  • Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
  • Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
  • Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
  • Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
  • Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.

Objective:

  • To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
  • To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Eligibility:

  • Age less than or equal to 21 years.
  • Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
  • Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
  • Measurable or evaluable tumor at the time of study entry.

Design:

  • This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
  • Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
  • Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 21年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

Age less than or equal to 21 years.

Patients entered on this trial will also be entered on one of the Pediatric Oncology Branch's primary treatment trials (e.g., phenylacetate, phenylbutyrate, SU-101) or on the Natural History or Standard Therapy protocols. The patient's management will be determined by the primary treatment protocol.

Histology confirmed primary or metastatic brain tumor. Patients with a brainstem glioma are not required to have previously had a histologic diagnosis.

Measurable or evaluable tumor at the time of study entry.

Durable Power of Attorney (DPA): A DPA is required of all patients 18 - 21 years of age.

All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate the minor patient will give verbal assent.

EXCLUSION CRITERIA:

Pregnant women.

Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies and who is not an anesthesia candidate.

Any patient with a metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.

Any patient with a history of a severe reaction to Gadolinium or other contrast agents.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.
大体时间:at time of disease evaluation
in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect
at time of disease evaluation

次要结果测量

结果测量
措施说明
大体时间
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema
大体时间:at time of disease evaluation
measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)
at time of disease evaluation
Determine if early metabolic changes are predictive of response
大体时间:at time of disease evaluation
Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery
at time of disease evaluation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1997年3月14日

研究完成

2019年5月6日

研究注册日期

首次提交

1999年11月3日

首先提交符合 QC 标准的

1999年11月3日

首次发布 (估计)

1999年11月4日

研究记录更新

最后更新发布 (实际的)

2019年5月8日

上次提交的符合 QC 标准的更新

2019年5月7日

最后验证

2019年5月6日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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