Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detectable fluorescence in brain tumors by confocal microscopy after oral dosing of demeclocycline (Y/N).
研究概览
简要总结
This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.
详细描述
This research study is a Feasibility Study, which is the first time investigators are examining this study intervention.The FDA (the U.S. Food and Drug Administration) has not approved Demeclocycline for your specific disease but it has been approved for other uses.
In this research study, the investigators would like to determine the lowest dose of Demeclocycline that will allow surgeons to detect tumor cells during surgery. These cells will be marked through a process called fluorescence, which will cause tumor cells to glow brightly on an image in comparison to its surroundings.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must present with a gadolinium-enhancing brain lesion (or lesions) that are thought by the neuroradiologist and the neurosurgeon to be consistent with high-grade glioma. These may be newly diagnosed lesions or recurrent tumors.
- •The patient must not be pregnant or nursing. Tetracycline (Demeclocycline, Doxycycline, Minocycline, Tetracycline, and Tigecycline) are classified as FDA pregnancy category D. Maternal ingestion of Tetracyclines during pregnancy may cause tooth discoloration, enamel defects, and other congenital anomalies. Tetracyclines are excreted in human breast milk; however, the extent of absorption of Tetracyclines by the breastfed infant is not known.
- •Participants must have normal organ and marrow function as defined below:
- •leukocytes ≥ 3,000/mcL
- •absolute neutrophil count ≥ 1,500/mcL
- •platelets ≥ 100,000/mcL
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SGPT) ≤ 4 × institutional upper limit of normal
- •creatinine < 2mg/dL
- •Ability to understand and the willingness to sign a written informed consent document.
- •Participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Demeclocycline.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or nursing women are excluded from this study because Demeclocycline is a known Teratogenic agent, pregnancy category D. It is known to be excreted in breast milk.
- •Patients taking etinoid medications by mouth (such as Acitretin, Isotretinoin), Strontium Ranelate may not take Demeclocycline because of toxic interactions
- •Patients taking any tetracycline class of drug (i.e. Minocycline, etc).
研究组 & 干预措施
Demeclocycline
All subjects will take Demeclocycline 300 mg po bid. Patients will be advised to take demeclocycline on an empty stomach, at least 1-2 hours before meals, and they will be warned that it can reduce the efficacy of oral contraceptives.
The investigators will begin by treating subjects with 2 days of demeclocycline. The investigators will increase the numbers of days that subjects are exposed to demeclocycline in increments of 1 day until at least 80% of patients at a given dose have detectably fluorescent tumors, or participants reach 5 days of drug, whichever comes first.
干预措施: Demeclocycline (Drug)
结局指标
主要结局
Detectable fluorescence in brain tumors by confocal microscopy after oral dosing of demeclocycline (Y/N).
时间窗: 2 years
Detectable fluorescence via confocal microscopy
次要结局
- Sensitivity And Specificity Of Demeclocycline-Enhanced Multimodal Confocal Microscopy of Excised Glioma Specimens(2 years)
研究者
William T. Curry, MD
William T. Curry, MD
Massachusetts General Hospital