2024-520426-11-00
Not yet recruiting
Phase 2
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.
DrugsFG001
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Copenhagen University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sensitivity detection of tumor tissue in meningioma with its dural attachment, and pLGG using histology as a reference.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
To evaluate FG001 for the detection of meningioma, or presumed low-grade glioma (pLGG).
Investigators
Leah Lehmann
Scientific
Copenhagen University Hospital
Eligibility Criteria
Inclusion 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)
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 (INR > 1,7, Estimated GFR (eGFR) <45 ml/min/1,73m2)
- •Unwilling or unable to follow the protocol requirements
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Efficacy (Demonstrate exposure of FG001)
- Safety and tolerability (Adverse Events, laboratory parameters, 12 - lead ECG parameters, vital signs)
Study Sites (1)
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