Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients With CNS Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery
研究概览
简要总结
This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
详细描述
PRIMARY OBJECTIVE:
I. To define the heterogeneity of blood brain barrier (BBB) permeability by assessing drug distribution in a population of patients with central nervous system (CNS) malignancy.
SECONDARY OBJECTIVE:
I. Establish correlation of BBB permeability with radiographic appearance for study patients.
CORRELATIVE RESEARCH OBJECTIVE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Age >= 18 years
- •Clinical and radiographic evidence suggesting CNS malignancy
- •Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR previously untreated or treated brain metastasis
- •Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester
- •Able to have magnetic resonance imaging (MRI) imaging with gadolinium contrast (e.g. no cardiac pacemaker, defibrillator, renal failure)
- •Females of childbearing potential must have a negative pregnancy test done =< 14 days prior to registration
- •Provide written informed consent
- •Willing to provide tissue and blood samples for research purposes
- •Patients having a study-specific surgical planning MRI only: Creatinine (estimated glomerular filtration rate [eGFR] >= 30) (obtained =< 30 days prior to registration)
排除标准
- •Vulnerable populations: pregnant women, prisoners, mentally handicapped
- •Unable to undergo a biopsy of CNS lesion
- •Documented drug allergy to cefazolin or levetiracetam, or other contraindication to use these drugs in the pre-operative setting (e.g., patient is already on another anti-seizure medication which precludes the clinical indication for pre-operative levetiracetam)
- •Patients who are unable to swallow tablets if study drug is administered by mouth
- •Patients who are at risk for impaired absorption of oral medication if study drug is administered by mouth; Note: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection
- •Pregnant or nursing women; Note: Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy; there is also a potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with these drugs, so breastfeeding should be discontinued for the duration of the study
结局指标
主要结局
Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery
时间窗: At the time of surgery
The ratio of cefazolin and levetiracetam (or lorazepam) and gadolinium in blood taken every 20-30 minutes during surgery will be correlated with the tissue samples. Inter- and intra-subject variability over all patients will be estimated, within specific imaging features between patients, and within open biopsy specimens.
次要结局
- Radiographic appearance at each tissue sample location(At the time of surgery)