NCT03451123终止早期 1 期
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI
研究概览
简要总结
The primary objectives of this study are:
- Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.
- Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.
A secondary objective of this study is:
- Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
- •Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
- •Patient must be 18 years of age or younger at the time of study enrollment.
- •Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
- •Patient must have a life expectancy greater than 8 weeks.
- •Patient must be able to undergo FET-PET/MRI without sedation.
- •Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.
排除标准
- •Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
- •Patient must not have received radiation therapy within the past 6 months.
- •Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
- •Patient must not be pregnant or breast feeding.
- •Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
- •Patients must not have a history of brain metastases.
研究组 & 干预措施
FET-PET/MRI
Experimental
O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI
干预措施: FET PET/MRI (Drug)
结局指标
主要结局
Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI
时间窗: 2 years
The percentage of patients with residual tumor identified with FET-PET/MRI will be measured. This percentage will be compared to detection of residual tumor by MRI alone.
Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone.
时间窗: 2 years
Surgical planning will be performed prior to brain tumor resection based on MRI alone and then with FET-PET/MRI. The surgical margins will be compared and the percentage of patients whose surgical plans change with FET-PET/MRI will be calculated.
次要结局
未报告次要终点
研究者
Jonathan E McConathy
Principal Investigator
University of Alabama at Birmingham
研究点 (1)
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