FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery (NCT06684795) | Clinical Trial Compass
RecruitingPhase 2
FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery
Denmark40 participantsStarted 2024-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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
. Unwilling or unable to follow the protocol requirements