Actively Recruiting
FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery
Led by Rigshospitalet, Denmark · Updated on 2024-11-12
40
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary brain tumor on MRI suggestive of meningioma or presumed low-grade glioma
- Scheduled for neurosurgery with the goal to remove cancer tissue
- Aged 18 years or older
- Able to understand and provide written informed consent
- Women of childbearing potential must agree to use effective contraception during the trial and for 30 days after
- Male subjects must agree to use barrier contraception during the trial and for 30 days after
- Have not previously received FG001
- Have normal organ and bone marrow function and be suitable surgical candidates according to standard care
You will not qualify if you...
- Known allergy or hypersensitivity to indocyanine green (ICG)
- Pregnant or breastfeeding women (must have negative pregnancy test and pause breastfeeding during trial and for 30 days after)
- Overall health or co-morbidities that make participation unsafe as judged by investigator
- Pre-existing liver or kidney problems, including INR above 1.7 or eGFR below 45 ml/min/1.73m2
- Unable or unwilling to follow protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
J
Jane Skjøth-Rasmussen, MD, PhD
CONTACT
A
Aleena Azam, MD, PhD student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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