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
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
- Primary objective
研究概览
简要总结
In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for the cure of the disease. None of the existing fluorescent drug is useful or approved for these tumors.. Hence a medicinal product that will fulfil the criteria for a safe and reliable fluorescent drug to guide the surgery to the boundaries of the infiltration with tumor cells is highly warranted.
详细描述
The drug FG001 (ICG-Glu-Glu-AE105), a uPAR-targeting fluorescent drug, has been tested in patients with high-grade glioma as part of a First-in-human clinical trial and demonstrated an excellent safety profile and efficacy results. Animal studies have indicated uptake of FG001 in low-grade glioma while uptake has been shown in one clinical case of meningioma providing the basis for this trial.
Consequently, the investigators intend to test the ability of FG001 to reliably fluoresce in patients with presumed low-grade glioma or meningioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects will be entered into this trial only if they meet all the following criteria:
- •Subjects diagnosed with primary brain tumor on MRI suggestive of, 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) *Presumed low-grade gliomas in this protocol are defined as diffusely infiltrated non-contrast enhancing tumors on MRI. Patients with known LGG scheduled for re-surgery or primary surgery after a diagnostic biopsy may also be included.
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 above 1.7
- •Estimated GFR (eGFR) below 45 ml/min/1.73m2
- •Unwilling or unable to follow the protocol requirements
研究组 & 干预措施
Presumed low-grade glioma
干预措施: FG001 prior to surgery (Drug)
Meningioma
干预措施: FG001 prior to surgery (Drug)
结局指标
主要结局
Primary objective
时间窗: 24 months
The primary objective is to evaluate the sensitivity of FG001 for detection of tumor tissue from meningioma and pLGG. The sensitivity will be evaluated as the proportion of subjects with fluorescent tumors given the tumor has been histologically verified.
次要结局
- Secondary outcome(24 months)
研究者
Jane Skjøth-Rasmussen
Principal Investigator
Rigshospitalet, Denmark