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FG001 in subjects with Meningiomas or presumed Low-Grade Gliomas scheduled for neurosurgery.
EU CTIS ID: 2024-520426-11-00
What this study is testing
To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.