Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT06684795
Eligibility Criteria:
Inclusion Criteria:
Subjects will be entered into this trial only if they meet all the following criteria:
1. Subjects diagnosed with primary brain tumor on MRI suggestive of, meningioma or presumed low-grade glioma (pLGG)\*
2. Scheduled for neurosurgery with the objective to remove cancer tissue
3. Subjects aged 18 years or older
4. Capable of understanding and giving written informed consent
5. 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)
6. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit.
7. Subject must not previously have received the trial drug (FG001)
8. 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:
1. Any known allergy or hypersensitivity to indocyanine green (ICG)
2. 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
3. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
4. Pre-existing hepatic and/or renal insufficiency
* INR above 1.7
* Estimated GFR (eGFR) below 45 ml/min/1.73m2
5. Unwilling or unable to follow the protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06684795
Study Brief:
Protocol Section:
NCT06684795