Not recruiting

Study on 68Ga-NOTA-Anti-HER2 VHH1 for Cancer Patients with Brain Metastasis

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 patients with cancer that has spread to the brain, known as brain metastasis. The trial will use a special treatment called 68Ga-NOTA-anti-HER2 VHH1, which is a solution for injection. This treatment is designed to help doctors see how well it targets cancer cells in the brain. The purpose of the study is to compare how this treatment is taken up in brain metastasis lesions in patients who have HER2-positive cancer and those who do not.

During the study, patients will receive the 68Ga-NOTA-anti-HER2 VHH1 injection through a vein, a method known as intravenous administration. The study will observe how the treatment is absorbed by the cancer cells in the brain. This will be done by a nuclear medicine doctor who will look at images to see if the treatment is working. The doctor will not know the HER2 status of the patients to ensure unbiased results. The study will also measure the uptake of the treatment using a method called Standard Uptake Values (SUV), which helps to quantify how much of the treatment is absorbed by the cancer cells.

If possible, the study will also look at how the uptake of the treatment changes during and after any other treatments the patients might be receiving. This information will be compared to the patients' overall disease progression. The study aims to provide valuable insights into the effectiveness of 68Ga-NOTA-anti-HER2 VHH1 in targeting brain metastasis in cancer patients, potentially leading to better treatment options in the future.

The research process

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

Step 1
Joining the study
Participation begins after providing informed consent. Eligibility requires being 18 years or older, having cancer with brain metastasis, and at least one brain lesion of 8 mm or more, as measured by CT or MRI.
Potential HER2-positive cancer is necessary. Either previous HER2 staining should have been done, or enough tissue should be available for HER2 staining for study purposes.
Step 2
Medication administration
The medication used is 68Ga-NOTA-anti-HER2 VHH1, a solution for injection.
It is administered through an intravenous injection. The frequency and duration of administration are determined by the study protocol.
Step 3
Evaluation of medication uptake
The main objective is to compare the uptake of 68Ga-NOTA-anti-HER2 VHH1 in brain metastasis lesions between HER2-positive and HER2-negative patients.
The tumor targeting potential in brain metastasis is visually scored as positive or negative by a nuclear medicine physician who is unaware of the HER2 status.
Quantitative assessment is done using Standard Uptake Values (SUV) by the same physician.
Step 4
Secondary evaluation
If available, uptake is evaluated during and after treatment and compared to baseline values.
Results are compared to information about the patient's disease course.
Step 5
Trial duration
The estimated end date for the trial is December 31, 2026.
The recruitment for the trial started on October 16, 2017.

Who can join the trial?

4 criteria

Patients must have given their informed consent, which means they agree to participate after understanding the study details.
Patients must be 18 years or older.
Patients must have cancer that has spread to the brain, known as **brain metastasis**, with at least one brain lesion (an abnormal area) that is at least 8 mm in size, as measured by a CT or MRI scan.
Patients must have cancer that is potentially **HER2-positive**. This means a test should have been done to check for HER2, a protein that can affect cancer growth, or there should be enough tissue available to do this test for the study.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with cancer that has spread to the brain.
Patients who are not within the specified age range for the study.
Patients who are not either HER2-positive or HER2-negative. HER2 is a protein that can affect the growth of cancer cells.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Vrije Universiteit Brussel
Verified
Jette, Belgium

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Investigated drugs

68GaNOTA-Anti-HER2 VHH1 is a special imaging agent used in this clinical trial. It is designed to help doctors see brain metastasis in cancer patients more clearly. This agent targets a protein called HER2, which is found on some cancer cells. By using this imaging agent, doctors can compare how it is taken up by brain metastasis in patients who have HER2-positive cancer versus those who have HER2-negative cancer. This helps in understanding the behavior of the cancer and planning the best treatment approach.

68Ganota-Anti-Her2 Vhh1

What is already known about the treatment

68GaNOTA-Anti-HER2 VHH1 – This medication is administered through an injection, typically used in imaging procedures. It is currently being studied in clinical trials to evaluate its effectiveness in detecting brain metastases in cancer patients. The main therapeutic indication is for patients with cancer that has spread to the brain, specifically those with HER2-positive or HER2-negative tumors. At the molecular level, it works by binding to the HER2 protein, which is often overexpressed in certain types of cancer cells, allowing for better imaging of these cells. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Brain Metastasis – Brain metastasis occurs when cancer cells spread from their original site to the brain. This condition is common in patients with cancers such as breast, lung, and melanoma. The cancer cells travel through the bloodstream or lymphatic system and form secondary tumors in the brain. Symptoms can vary depending on the location and size of the metastasis and may include headaches, seizures, or neurological deficits. The progression of brain metastasis can lead to increased pressure within the skull, affecting brain function. The condition requires careful monitoring to understand its impact on the patient's overall health.