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Study on Detecting Untreated Brain Metastases in Lung, Breast, and Melanoma Cancer Patients Using Fluorodopa (18F)

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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 brain metastases, which are cancerous growths that have spread to the brain from other parts of the body. Specifically, the study looks at brain metastases originating from non-small cell lung cancer, breast cancer, and melanoma. The trial uses a special imaging technique called PET-DOPA, which involves a solution for injection known as Dopacis. This solution contains a substance called fluorodopa (18F), which helps in detecting these brain metastases.

The purpose of the study is to determine how effective PET-DOPA is in identifying newly diagnosed, untreated brain metastases that are at least 5 mm in size, as seen on an MRI scan. Participants in the study will undergo PET-DOPA imaging to see how well it can detect these metastases compared to traditional MRI scans. The study will also explore how PET-DOPA can help in understanding the characteristics of these brain metastases.

Throughout the study, participants will receive the PET-DOPA injection and undergo imaging to assess the presence and characteristics of brain metastases. The study aims to provide valuable information on the sensitivity of PET-DOPA in detecting brain metastases from different types of primary cancers, including specific subtypes of lung cancer, melanoma, and breast cancer. This research could potentially lead to better diagnostic tools for patients with these conditions.

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 study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of primary cancer (non-small cell lung, breast, or melanoma) and the presence of brain metastases larger than 5 mm as seen on an MRI scan.

    Eligibility criteria also require participants to be 18 years or older.

  2. Step 2

    Preparation for imaging

    Participants are prepared for imaging procedures. This involves understanding the process and purpose of the PET-DOPA scan, which is used to detect and characterize brain metastases.

  3. Step 3

    Administration of <b>fluorodopa (18f)</b>

    The medication fluorodopa (18f) is administered intravenously. This is a solution for injection known as Dopacis 90 MBq/ml.

    The purpose of this medication is to enhance the imaging results during the PET-DOPA scan.

  4. Step 4

    PET-DOPA scan

    A PET-DOPA scan is performed to detect brain metastases. This scan helps in identifying the number and characteristics of metastases compared to those detected by MRI.

    The scan provides detailed images that assist in understanding the metabolic activity of the brain metastases.

  5. Step 5

    Analysis of imaging results

    The results from the PET-DOPA scan are analyzed. This includes comparing the number of metastases detected on the PET-DOPA scan with those seen on the MRI.

    Additional analysis involves evaluating the sensitivity of the scan and characterizing lesions based on specific criteria such as SUVmax and SUVmean.

  6. Step 6

    Follow-up and conclusion

    Participants may undergo follow-up assessments to monitor any changes in the condition of the brain metastases.

    The study aims to conclude by March 3, 2026, with the primary objective of defining the sensitivity of PET-DOPA in detecting brain metastases.

Who can join the trial?

3 criteria

  • The patient must have a **confirmed diagnosis** of one of the following primary cancers: non-small cell lung cancer, breast cancer, or melanoma. This means that tests have shown the patient has one of these types of cancer.
  • The patient must have **brain metastases**. This means that the cancer has spread to the brain. These metastases must be visible on an **MRI scan**, which is a type of imaging test that uses magnets and radio waves to create pictures of the inside of the body. At least one of these metastases must be larger than 5 millimeters.
  • The patient must be **18 years of age or older**. This means the study is only for adults.

Who cannot join the trial?

1 criterion

  • Patients with brain tumors that have spread from other parts of the body, such as the lungs, breast, or skin (melanoma), and are larger than 5 mm as seen on an MRI scan.
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Investigated drugs

PET-DOPA is a special imaging agent used in this clinical trial to help detect and characterize brain metastases from breast, lung, and melanoma cancers. It works by highlighting areas of the brain that may have cancerous growths, making them visible on a PET scan. This helps doctors see if there are any new, untreated cancerous spots in the brain that are at least 5 mm in size.

What is already known about the treatment

PET-DOPA – This medication is administered through an intravenous injection and is used in conjunction with PET scans to detect brain metastases. It is currently being studied in clinical trials to assess its effectiveness in identifying brain metastases from lung, breast, and melanoma cancers. The main therapeutic indication is for patients with newly discovered brain metastases larger than 5 mm. PET-DOPA works by highlighting areas of increased metabolic activity in the brain, which can indicate the presence of cancer cells. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

  • Non-Small Cell Lung Cancer

    This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, including the brain, leading to brain metastases. Brain metastases can cause neurological symptoms such as headaches, seizures, and changes in behavior or cognition.

  • Breast Cancer

    This is a cancer that forms in the cells of the breasts, most commonly in the ducts or lobules. It can present as a lump in the breast, changes in breast shape, or skin dimpling. As it progresses, breast cancer can spread to other parts of the body, including the brain, resulting in brain metastases. Brain metastases from breast cancer can lead to symptoms like headaches, vision changes, and difficulty with balance or coordination. The progression of the disease varies depending on the subtype and other factors.

  • Melanoma

    This is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is often characterized by the appearance of a new mole or a change in an existing mole. Melanoma can be aggressive and may spread to other parts of the body, including the brain, forming brain metastases. Brain metastases from melanoma can cause symptoms such as headaches, seizures, and neurological deficits. The progression of melanoma can vary widely based on factors like the stage at diagnosis and genetic mutations.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515850-26-00Protocol codeICO-202-28 DOPACEREstimated enrolment52 patientsSponsorInstitut De Cancerologie De L Ouest

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