2024-520426-11-00招募中2 期
An open-label, non-randomized, single dose, phase II trial of FG001 (an optical imaging agent) for localization of Meningiomas or presumed Low- Grade Gliomas scheduled for neurosurgery.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.
研究概览
简要总结
To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with primary brain tumor on MRI suggestive of primary meningioma or presumed low-grade glioma (pLGG)
- •Scheduled for neurosurgery with the objective to remove cancer tissue
- •Subjects aged 18 years or older
- •Capable of understanding and giving written informed consent
- •Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
- •Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit
- •Subject must not previously have received the trial drug (FG001)
- •Subjects must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC)
排除标准
- •Any known allergy or hypersensitivity to indocyanine green (ICG)
- •Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion (or if breast- feeding willing to pause breast feeding during trial and for 30 days
- •Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
- •Pre-existing hepatic and/or renal insufficiency (INR > 1,7, Estimated GFR (eGFR) <45 ml/min/1,73m2)
- •Unwilling or unable to follow the protocol requirements
结局指标
主要结局
Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.
Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.
次要结局
- Efficacy (Demonstrate exposure of FG001)
- Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)
研究者
Leah Lehmann
Scientific
Copenhagen University Hospital
研究点 (1)
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