NCT00276770已完成不适用
NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine F 18, may be effective in finding recurrent disease in patients with gliomas.
PURPOSE: This clinical trial is studying how well positron emission tomography using fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.
详细描述
OBJECTIVES:
Primary
- Determine the safety of fluorothymidine F 18 for visual and dynamic brain tumor images in patients with glial neoplasms.
- Determine, preliminarily, the efficacy of this drug.
Secondary
- Compare, preliminarily, the efficacy of this drug to fludeoxyglucose F 18 in differentiating tumor recurrence from radiation necrosis.
- Determine the optimal time to image post injection of this drug.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Radiological or established histological diagnosis of glioma
- •WHO grade 2-4 disease
- •Presence of a new or enlarging enhancing lesion on gadolinium-enhanced MRI after prior radiotherapy
- •Differentiation of recurrent tumor from radiation necrosis is not possible
- •No clinically significant signs of uncal herniation, including any of the following:
- •Acute pupillary enlargement
- •Rapidly developing (i.e., over hours) motor changes
- •Rapidly decreasing level of consciousness
- •PATIENT CHARACTERISTICS:
- •Platelet count ≥ 75,000/mm^3
- •WBC ≥ 3,000/mm^3
- •Gamma-glutamyl-transferase ≤ 5 times upper limit of normal (ULN)
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 10 g/dL
- •SGOT and SGPT ≤ 2 times ULN
- •Alkaline phosphatase ≤ 2 times ULN
- •Lactic dehydrogenase ≤ 2 times ULN
- •Direct and total bilirubin normal
- •Amylase normal
- •Haptoglobin normal
- •Serum electrolytes normal
- •CBC with platelets normal
- •PT, PTT normal
- •BUN and creatinine normal
- •Not pregnant or lactating
- •Urinalysis normal
- •Negative pregnancy test
- •Female patients must be postmenopausal for ≥ 1 year or surgically sterile, or on 1 of the following methods of birth control for ≥ 1 month: IUD, oral contraceptives, Depo-Provera, or Norplant
- •These criteria can be waived at the discretion of the investigator if the patient's intracranial tumor is considered life threatening and the 1-month wait required is not in the best interest of the patient
- •No known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
- •No known HIV positivity
- •Not requiring monitored anesthesia for positron emission tomography scanning
- •PRIOR CONCURRENT THERAPY:
- •Concurrent biopsy or neurosurgical procedure for diagnostic and/or therapeutic purposes for this cancer allowed
- •Concurrent surgery for this cancer allowed
排除标准
- 未提供
研究者
研究点 (1)
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