Using FG001 to help remove low-grade gliomas and meningiomas during surgery
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
PHASE2 · Rigshospitalet, Denmark · NCT06684795
This study is testing a special fluorescent drug called FG001 to see if it can help surgeons find and remove low-grade gliomas and meningiomas more effectively during surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT06684795 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of FG001, a fluorescent drug, in assisting neurosurgeons to identify and remove low-grade gliomas and meningiomas. FG001 has previously shown safety and efficacy in high-grade glioma patients and has demonstrated potential uptake in low-grade gliomas and meningiomas in preliminary studies. The trial will involve administering FG001 prior to surgery to assess its ability to fluoresce and delineate tumor boundaries from healthy tissue, which is crucial for complete tumor resection.
Who should consider this trial
Good fit: Ideal candidates for this trial are adults aged 18 and older diagnosed with low-grade gliomas or meningiomas who are scheduled for neurosurgery.
Not a fit: Patients with high-grade gliomas or those not scheduled for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes by ensuring more complete removal of tumor tissue, potentially enhancing patient prognosis.
How similar studies have performed: While FG001 has shown promise in high-grade gliomas, this specific application for low-grade gliomas and meningiomas is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen, Capital Region
- Rigshospitalet — Copenhagen, Capital Region, Denmark (RECRUITING)
Study contacts
- Principal investigator: Jane Skjøth-Rasmussen, MD, PhD — Department of neurosurgery, Rigshospitalet
- Study coordinator: Jane Skjøth-Rasmussen, MD, PhD
- Email: jane.skjoeth-rasmussen@regionh.dk
- Phone: +4535451446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low-grade Glioma, Meningioma, Glioma