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Study Comparing [18F]meta-fluorobenzylguanidine PET-CT and Iodine (123I) Iobenguane Scans for Detecting Neuroblastoma in Patients

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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 neuroblastoma, a type of cancer that most often affects children and develops from immature nerve cells. The study will compare two different imaging methods used to detect this disease. The first method uses a substance called [18F]meta-fluorobenzylguanidine (also known as [18F]mFBG) in a type of scan called PET-CT. The second method uses iodine (123I) iobenguane (also known as [123I]mIBG) in a scan called SPECT-CT. Both substances are injected into the body and help to highlight areas where the cancer might be present.

The purpose of this study is to compare how well these two imaging methods can detect cancer in the bones of patients with neuroblastoma. Participants in the study will undergo both types of scans, and the results will be compared to see which method is more effective at finding cancerous lesions. The study will also look at other factors, such as the amount of radiation absorbed by the body during each type of scan and the number of cancerous areas detected.

This study is expected to take place over several years, with the goal of improving the way neuroblastoma is diagnosed and monitored. By comparing these two imaging methods, researchers hope to find the most accurate and safe way to detect this type of cancer, which could lead to better treatment outcomes for patients in the future.

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 the clinical suspicion of neuroblastoma.

    This assessment includes a review of medical history and any previous imaging results.

  2. Step 2

    Consent process

    Written informed consent is required from the patient or their legal guardians, in accordance with local laws and regulations.

    This step ensures understanding and agreement to participate in the study.

  3. Step 3

    First imaging session

    The first imaging session involves a [123I]mIBG scan, which is a conventional imaging method used to detect skeletal lesions.

    A solution for injection containing iodine (123i) iobenguane is administered.

    The scan helps in identifying any skeletal lesions present.

  4. Step 4

    Second imaging session

    The second imaging session uses [18F]mFBG PET-CT, a newer imaging technique.

    A solution for injection containing [18f]meta-fluorobenzylguanidine is administered.

    This session aims to compare the detection of skeletal lesions with the previous [123I]mIBG scan.

  5. Step 5

    Data analysis

    The results from both imaging sessions are analyzed to compare the diagnostic performance of the two methods.

    The primary focus is on the detection of skeletal lesions, while secondary analyses include soft tissue lesions and radiation doses.

  6. Step 6

    Follow-up

    Follow-up appointments may be scheduled to discuss the findings and any further steps in the patient's care.

    The study aims to conclude by October 18, 2027, with recruitment starting on September 16, 2024.

Who can join the trial?

4 criteria

  • The patient must have a **clinical suspicion of neuroblastoma** or be referred for a specific type of imaging called **[123I]mIBG imaging**. Neuroblastoma is a type of cancer that usually affects young children.
  • There must be **written informed consent** from the patient and/or their parents or legal guardians. This means they agree to participate in the study after being fully informed about it, following local laws and regulations.
  • The study includes both **male and female** patients.
  • The study is open to patients who are considered part of a **vulnerable population**, which often includes children or those who may need special protection.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed or suspected case of neuroblastoma cannot participate. Neuroblastoma is a type of cancer that usually affects young children.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who do not meet the gender requirements for the study cannot participate. The study is open to both male and female participants.
  • Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

  • [18F]mFBG

    is a type of imaging agent used in PET-CT scans. It helps doctors see detailed images of the body, particularly to detect skeletal lesions in patients with neuroblastoma. This imaging agent is being studied to see if it provides better diagnostic information compared to other methods.

  • [123I]mIBG

    is another imaging agent used in SPECT-CT scans. It is commonly used to detect neuroblastoma, a type of cancer that often affects children. This agent helps in visualizing the spread of cancer in the body, especially in the bones. The study aims to compare its effectiveness with the newer agent, [18F]mFBG.

What is already known about the treatment

  • [18F]mFBG

    This medication is administered through a PET-CT scan, a type of imaging test. It is currently being studied in clinical trials to evaluate its effectiveness in diagnosing neuroblastoma, a type of cancer that occurs in children. The main therapeutic indication is to detect skeletal lesions associated with neuroblastoma. At the molecular level, [18F]mFBG works by binding to certain receptors on cancer cells, allowing them to be visualized during the PET-CT scan. It is classified as a radiopharmaceutical used for diagnostic imaging.

  • [123I]mIBG

    This medication is administered through a SPECT-CT scan, another form of imaging test. It is a well-established method in medical literature for diagnosing neuroblastoma. The primary therapeutic indication is to identify and assess the extent of neuroblastoma in the body. The mechanism of action involves the uptake of the radioactive iodine-labeled compound by neuroblastoma cells, which can then be detected by the SPECT-CT scan. It is also classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and arises from immature nerve cells found in several areas of the body. It typically begins in the adrenal glands, which are located on top of the kidneys, but can also develop in the neck, chest, abdomen, or spine. The disease can spread to other parts of the body, including the bones, liver, and skin. Symptoms may vary depending on the location of the tumor and can include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it may cause fatigue, loss of appetite, and weight loss. Neuroblastoma is considered a rare disease and its progression can vary significantly from one individual to another.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501694-39-01Protocol codePS22PETEstimated enrolment58 patientsSponsorPrincess Maxima Center For Pediatric Oncology

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