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Study on Using [68Ga]NOTA-AE105 to Visualize and Differentiate Gliomas in Patients

Verified siteInvestigationalNo 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 a type of brain tumor known as glioma. The study uses a special imaging technique called uPAR PET/MRI to help visualize these tumors. The imaging involves a tracer called [68Ga]NOTA-AE105, which is a solution injected into the body. This tracer helps to highlight the tumor on the scan by showing areas with high levels of a protein called uPAR, which is often found in gliomas.

The purpose of the study is to see if the uPAR PET/MRI can effectively show the presence of gliomas and help differentiate between high-grade and low-grade gliomas. It also aims to distinguish between tumor progression and changes that occur after treatment. The study will observe how the uptake of the tracer relates to the levels of uPAR in the tumor, which is determined by examining tissue samples from the tumor.

Participants in the study will undergo the uPAR PET/MRI scan, and the results will be compared with tissue samples to assess the accuracy of the imaging. The study will also look at how the levels of uPAR in the tumor might relate to the patient's survival over a period of 36 months. This research could provide valuable insights into the diagnosis and treatment planning for patients with glioma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing imaging results such as brain MRI or CT scans that suggest the presence of a glioma.

    Eligibility is confirmed for individuals over 18 years old who can understand the study information and provide informed consent.

  2. Step 2

    Injection of tracer

    The patient receives an injection of a solution called [68Ga]NOTA-AE105. This is administered through a vein, a process known as intravenous administration.

    The solution is used to help visualize the glioma during imaging procedures.

  3. Step 3

    Imaging procedure

    Within one hour after the injection, a specialized imaging procedure called uPAR-PET/MRI is performed.

    This scan helps to visualize the glioma by detecting the uptake of the tracer [68Ga]NOTA-AE105.

  4. Step 4

    Evaluation of results

    The results from the imaging procedure are evaluated to determine the standard uptake values (SUVs) of the tracer.

    These values are compared with laboratory analysis of tumor samples to assess the expression of a protein called uPAR.

  5. Step 5

    Follow-up period

    The patient is monitored for a total of 36 months after the initial imaging procedure.

    During this period, the significance of uPAR expression is evaluated in relation to overall survival and progression-free survival.

Who can join the trial?

6 criteria

  • Patients must be **18 years or older**.
  • There must be a **suspicion of glioma**, a type of brain tumor, based on imaging tests like MRI or CT scans.
  • Patients should be **scheduled for a biopsy**, which is a procedure to take a small sample of tissue, or for surgery or cancer treatment.
  • Patients must be able to **understand the information** about the study and **agree to participate** by giving their consent.
  • Both **men and women** can participate in the study.
  • The study does not include **vulnerable populations**, which means groups that might need special protection or care.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with a glioma, which is a type of brain tumor, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.
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Investigated drugs

68Ga-NOTA-AE105 is a special tracer used in imaging tests like PET/MRI or PET/CT scans. In this clinical trial, it helps doctors see gliomas, which are a type of brain tumor. The tracer works by attaching to a specific protein called uPAR that is found in these tumors. By doing this, it helps doctors understand how aggressive the tumor is and whether it is growing back after treatment. This information can be very important for planning the best treatment approach for patients with gliomas.

What is already known about the treatment

68Ga-NOTA-AE105 – This medication is administered through an injection and is used in PET/MRI or PET/CT imaging to visualize gliomas, a type of brain tumor. It is currently being studied in clinical trials to assess its effectiveness in differentiating between high-grade and low-grade gliomas, as well as distinguishing tumor progression from post-treatment effects. The main therapeutic indication is for imaging in patients with glioma. At the molecular level, 68Ga-NOTA-AE105 binds to the uPAR receptor, which is often overexpressed in gliomas, allowing for targeted imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Glioma – Glioma is a type of tumor that occurs in the brain and spinal cord. It originates from glial cells, which are supportive cells in the nervous system. Gliomas can vary in their growth rate and are classified into different grades, with high-grade gliomas growing more rapidly than low-grade ones. Symptoms depend on the tumor's location and size and may include headaches, seizures, and neurological deficits. As the disease progresses, it can lead to increased pressure within the skull and further neurological complications. The progression of gliomas can be influenced by various factors, including genetic mutations and cellular changes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519723-20-01Protocol code2016-002417-21Estimated enrolment61 patientsSponsorRegion Hovedstaden

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