A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
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
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
注册 (实际的)
联系人和位置
学习地点
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Maryland
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Bethesda、Maryland、美国、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect
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at time of disease evaluation
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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
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measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)
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at time of disease evaluation
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Determine if early metabolic changes are predictive of response
大体时间:at time of disease evaluation
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Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery
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at time of disease evaluation
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合作者和调查者
出版物和有用的链接
一般刊物
- Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.
- Sutton LN, Wang Z, Gusnard D, Lange B, Perilongo G, Bogdan AR, Detre JA, Rorke L, Zimmerman RA. Proton magnetic resonance spectroscopy of pediatric brain tumors. Neurosurgery. 1992 Aug;31(2):195-202. doi: 10.1227/00006123-199208000-00004.
- Duyn JH, Gillen J, Sobering G, van Zijl PC, Moonen CT. Multisection proton MR spectroscopic imaging of the brain. Radiology. 1993 Jul;188(1):277-82. doi: 10.1148/radiology.188.1.8511313.
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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