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Study of FG001 for Detecting Meningioma or Low-Grade Glioma in Patients Undergoing Neurosurgery

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two types of brain tumors: Meningioma and Glioma. The study will use a special treatment called FG001, which is an optical imaging agent. This means it helps doctors see the tumors more clearly during surgery. The purpose of the study is to evaluate how well FG001 can help in detecting these brain tumors when patients are scheduled for surgery to remove them.

Participants in the study will receive a single dose of FG001 through an intravenous infusion, which means it will be given directly into a vein. The study is designed to observe how effectively FG001 highlights the tumor tissue, making it easier for surgeons to locate and remove the tumors. The study will also monitor the safety and any side effects of using FG001 during the surgical procedure.

The trial aims to provide valuable information on the use of FG001 in helping surgeons identify and remove Meningioma and Glioma tumors more accurately. This could potentially improve surgical outcomes for patients with these types of brain tumors. The study will continue until 2026, with the recruitment of participants expected to start in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the diagnosis of a primary brain tumor, such as meningioma or presumed low-grade glioma, as indicated by MRI.

    Eligibility criteria include being scheduled for neurosurgery to remove cancer tissue, being 18 years or older, and having the ability to understand and provide written consent.

  2. Step 2

    Preparation for medication

    Before the administration of the trial medication, participants are informed about the use of FG001, an optical imaging agent designed to help locate brain tumors during surgery.

    Participants must not have previously received FG001 and must have normal organ and bone marrow function.

  3. Step 3

    Medication administration

    FG001 is administered as a single dose through an intravenous infusion. This involves receiving the medication through a vein, using a vial specifically for intravenous use.

    The purpose of FG001 is to enhance the detection of tumor tissue during surgery.

  4. Step 4

    Surgical procedure

    Following the administration of FG001, the scheduled neurosurgery is performed. The goal is to remove the cancer tissue, with the aid of the imaging agent to better locate the tumor.

    The effectiveness of FG001 in highlighting tumor tissue is evaluated during this procedure.

  5. Step 5

    Post-surgery evaluation

    After surgery, the sensitivity of FG001 in detecting tumor tissue is assessed using histology, which involves examining tissue samples under a microscope.

    Participants are monitored for any adverse effects, and safety parameters such as laboratory tests, ECG, and vital signs are evaluated.

  6. Step 6

    Follow-up

    Participants are required to attend follow-up visits to monitor their recovery and any long-term effects of the trial medication.

    Both male and female participants must adhere to specific contraception guidelines for 30 days following the end-of-trial visit to ensure safety.

Who can join the trial?

8 criteria

  • Subjects must have a primary brain tumor seen on an MRI scan that looks like a primary meningioma or a presumed low-grade glioma (pLGG). A meningioma is a type of tumor that forms in the membranes covering the brain and spinal cord. A glioma is a type of tumor that occurs in the brain and spinal cord.
  • Subjects must be scheduled for brain surgery to remove cancer tissue.
  • Subjects must be 18 years old or older.
  • Subjects must be able to understand and sign a written consent form agreeing to participate in the study.
  • Women who can have children must agree to use a reliable form of birth control during the study and for 30 days after the study ends. Reliable methods include devices placed inside the body or hormonal methods like pills, injections, implants, patches, or rings. Women are considered unable to have children if they have had surgery to remove or block reproductive organs or have not had a menstrual period for at least 12 months.
  • Men must agree to use a condom during the study and for 30 days after the study ends.
  • Subjects must not have taken the study drug, FG001, before.
  • Subjects must have normal functioning of their organs and bone marrow and be suitable for surgery according to the standard care at the study site.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with a meningioma or a glioma. A meningioma is a type of tumor that forms on the membranes covering the brain and spinal cord. A glioma is a type of tumor that occurs in the brain and spinal cord.
  • Patients who are not within the specified age range for the study. The study includes certain age groups, and patients outside these groups cannot participate.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as those with certain disabilities or conditions.
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Investigated drugs

FG001 is an optical imaging agent used in this clinical trial. It helps doctors locate meningiomas or presumed low-grade gliomas during neurosurgery. This agent is designed to make these types of brain tumors more visible, allowing surgeons to identify and remove them more accurately.

What is already known about the treatment

FG001 – FG001 is an optical imaging agent administered intravenously, designed to assist in the localization of brain tumors such as meningiomas and low-grade gliomas during neurosurgery. Currently, it is in phase II clinical trials, with ongoing research to establish its effectiveness and safety. The main therapeutic indication for FG001 is to enhance the visualization of these tumors, aiding surgeons in their precise removal. At the molecular level, FG001 works by binding to specific tumor cells, making them more visible under certain imaging techniques. It is classified pharmacologically as an imaging agent, specifically used in the context of neurosurgical procedures.

Investigated diseases

  • Meningioma

    Meningioma is a type of tumor that forms on the membranes covering the brain and spinal cord just inside the skull. It is usually slow-growing and can vary in size. As it grows, it may press on the brain or spinal cord, potentially causing symptoms like headaches or vision problems. Meningiomas are often benign, meaning they are not cancerous, but their location can still lead to significant effects on neurological function. They are more common in older adults and can sometimes be associated with genetic conditions. The exact cause of meningiomas is not well understood, but they are thought to arise from the meninges, the protective layers of tissue surrounding the brain and spinal cord.

  • Glioma

    Glioma is a type of tumor that occurs in the brain and spinal cord, originating from glial cells, which support and protect nerve cells. These tumors can vary widely in their growth rate and potential to spread. Low-grade gliomas tend to grow slowly and may not cause symptoms immediately, but as they enlarge, they can affect brain function. Symptoms can include headaches, seizures, or changes in personality or memory. Gliomas are classified based on the type of glial cell involved and their appearance under a microscope. The exact cause of gliomas is not fully understood, but genetic factors and exposure to radiation may play a role.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520426-11-00Protocol codeRH-FG001-001Estimated enrolment40 patientsSponsorCopenhagen University Hospital

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