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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
16.09.2024

Trial locations

[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.

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 ID:
2022-501694-39-01
Protocol code:
PS22PET
Trial Phase:
Human Pharmacology (Phase I) – Other

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