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Low-grade GliomaPhase 2NCT06684795

FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery

A Phase 2 study testing FG001 prior to surgery in people with Low-grade Glioma and Meningioma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low-grade Glioma, Meningioma, Glioma
What is being tested?
FG001 prior to surgery
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteDenmark
Study dates
1 May 2024to 1 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be entered into this trial only if they meet all the following criteria:
  • Subjects diagnosed with primary brain tumor on MRI suggestive of, 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)
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  • 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) *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.

Who cannot join

  • 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 above 1.7
  • Estimated GFR (eGFR) below 45 ml/min/1.73m2
  • Unwilling or unable to follow the protocol requirements

Trial locations and contacts

1 site in 1 country.

Jane Skjøth-Rasmussen, MD, PhD contact

+4535451446

jane.skjoeth-rasmussen@regionh.dk

Aleena Azam, MD, PhD student contact

+4535456208

aleena.azam@regionh.dk

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, Capital Region, 2100

    Jane Skjøth-Rasmussen, MD, PhD, +4535451446, jane.skjoeth-rasmussen@regionh.dk

    Aleena Azam, MD, PhD student, +4535456208, aleena.azam@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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

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.

Read the detailed description

The drug FG001 (ICG-Glu-Glu-AE105), a uPAR-targeting fluorescent drug, has been tested in patients with high-grade glioma as part of a First-in-human clinical trial and demonstrated an excellent safety profile and efficacy results. Animal studies have indicated uptake of FG001 in low-grade glioma while uptake has been shown in one clinical case of meningioma providing the basis for this trial.

Consequently, the investigators intend to test the ability of FG001 to reliably fluoresce in patients with presumed low-grade glioma or meningioma.

Being tested
FG001 prior to surgery
Medical subject headings
Meningioma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG001 prior to surgeryDrug

    Patients will receive a single intravenous injection of 36 mg FG001 administered the day before surgery.

Study groups in NCT06684795
Study groupRoleWhat they receive
Presumed low-grade gliomaExperimentalNot described
Receives: Drug: FG001 prior to surgery
MeningiomaExperimentalNot described
Receives: Drug: FG001 prior to surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary objective

    The primary objective is to evaluate the sensitivity of FG001 for detection of tumor tissue from meningioma and pLGG. The sensitivity will be evaluated as the proportion of subjects with fluorescent tumors given the tumor has been histologically verified.

    Measured: 24 months

Secondary outcomes (1)

  1. Secondary outcome

    The efficacy of FG001 as a tumor imaging agent and safety will be monitored. The efficacy is examined by the sensitivity and specificity. Sensitivity is defined as the probability that a test result is positive when the subject has the disease, while specificity is the probability that a test result is negative when the patient does not have the disease. Safety is determined by physical examinations, laboratory samples and the incidence and severity of the Adverse events (AEs), which are evaluated by National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 May 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A total of 40 patients are planned for enrolment. The study will include two arms, where one arm will consist of patients with presumed low-grade gliomas (pLGG) and one with meningiomas. Initially, 20 patients (pLGG=10 and meningioma=10) will be enrolled in the trial followed by an interim analysis. Here, further modifications in the trial with respect to dose administration time and administered dose is possible before enrolment of the last 20 patients (pLGG=10 and meningioma=10).
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684795
Sponsor's protocol ID
RH-FG001-001
Status last verified
Jun 2024
First submitted
20 Jun 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Witt Hamer PC, Robles SG, Zwinderman AH, Duffau H, Berger MS. Impact of intraoperative stimulation brain mapping on glioma surgery outcome: a meta-analysis. J Clin Oncol. 2012 Jul 10;30(20):2559-65. doi: 10.1200/JCO.2011.38.4818. Epub 2012 Apr 23.

    PubMed 22529254

  • Skjoth-Rasmussen J, Azam A, Larsen CC, Scheie D, Juhl K, Kjaer A. A new uPAR-targeting fluorescent probe for optical guided intracranial surgery in resection of a meningioma-a case report. Acta Neurochir (Wien). 2022 Jan;164(1):267-271. doi: 10.1007/s00701-021-05051-3. Epub 2021 Nov 8.

    PubMed 34748074

  • Skjoth-Rasmussen J, Azam A, Juhl K, Ginsborg S, Kryspin Sorensen M, Solling C, Larsen CC, Winther Kristensen B, Scheie D, Kjaer A. Novel Urokinase-Type Plasminogen Activator Receptor-Targeting Optical Imaging Agent ICG-Glu-Glu-AE105 for Visualization of Malignant Glioma During Surgery: First-in-Human Study in 35 Patients with Brain Cancer. Neurosurgery. 2025 Dec 1;97(6):1418-1427. doi: 10.1227/neu.0000000000003542. Epub 2025 Jun 3.

    PubMed 40459950

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FG001 prior to surgery in people with Low-grade Glioma and Meningioma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jane Skjøth-Rasmussen, MD, PhD (+4535451446, jane.skjoeth-rasmussen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary objective (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684795, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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