Study on the Safety of 68Ga-SATO and Iodine (123I) Iobenguane in Children with Neuroblastoma

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What is this study about?

This clinical trial is focused on studying neuroblastoma, a type of cancer that most commonly affects children. The study is exploring the use of a new treatment called 68Ga-SATO, which is a solution for injection. This treatment involves a substance known as satoreotide trizoxetan gallium (Ga68). The purpose of the study is to assess the short-term safety and tolerability of this new treatment in children with neuroblastoma.

Participants in the study will receive the 68Ga-SATO treatment through an injection. The study will also involve comparing the effectiveness of 68Ga-SATO imaging with current standard imaging methods, such as M123IBG scintigraphy and, if available, whole-body MRI. This comparison aims to determine how well the new treatment can detect cancer lesions compared to existing methods.

Throughout the study, researchers will monitor the safety of the treatment and gather information on how the body absorbs the radiation from 68Ga-SATO. The study will also evaluate the time required for preparing and conducting the imaging procedure. The trial is expected to continue until December 2025, providing valuable insights into the potential benefits and safety of 68Ga-SATO for children with neuroblastoma.

1 joining the study

Upon joining the study, ensure that a legal representative has provided written informed consent. If applicable, provide assent consent.

Eligibility includes being between the ages of 0-18 years and having a clinical suspicion of neuroblastoma or being referred for follow-up imaging.

2 initial assessment

Undergo an initial assessment to confirm eligibility and gather baseline health information.

This may include a review of medical history and any necessary preliminary tests.

3 administration of 68Ga-SATO

Receive an injection of 68Ga-SATO, a solution administered intravenously.

The purpose is to assess the short-term safety and tolerability of this medication in pediatric patients with neuroblastoma.

4 imaging procedures

Undergo PET/CT imaging to evaluate the effectiveness of 68Ga-SATO in detecting lesions.

This imaging will be compared to the current clinical standard of M123IBG scintigraphy and, if available, whole-body MRI.

5 monitoring and follow-up

Participate in follow-up visits to monitor any side effects and gather additional data on the safety and tolerability of 68Ga-SATO.

These visits will also help calculate the radiation absorbed dose in a subset of patients using dynamic PET imaging.

6 completion of study

Upon completion of the study, a final assessment will be conducted to evaluate overall health and gather final data.

The study is estimated to conclude by December 1, 2025.

Who Can Join the Study?

Age between 0 and 18 years old
Written informed consent from a legal representative, and assent consent from the patient if applicable. This means that a parent or guardian must agree to the study, and the child should also agree if they are old enough to understand.
Patients with a clinical suspicion of neuroblastoma who are referred for the first time for conventional M123IBG imaging. This is a type of scan used to look for neuroblastoma.
Patients with known neuroblastoma who are referred for follow-up M123IBG imaging. This means patients who have already been diagnosed with neuroblastoma and need another scan.

Who Cannot Join the Study?

Patients who do not have neuroblastoma cannot participate. Neuroblastoma is a type of cancer that usually affects children.
Patients who are not within the specified age range for the study cannot participate. The study is for children.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are taking certain medications that might interfere with the study cannot participate.
Patients who have had a recent surgery or medical procedure that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

Where you can join this trial?

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Other Sites

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

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2022

Trial locations

68Ga-SATO is a special type of imaging agent used in medical scans. It is designed to help doctors see certain types of cancer cells in the body, specifically in children with a type of cancer called neuroblastoma. This medication is not used to treat the cancer itself but helps in diagnosing and understanding the extent of the disease. During the trial, doctors will check how safe it is for children to use and how well it helps in getting clear images of the cancer.

Investigated diseases:

Neuroblastoma

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 progresses as the cancer cells grow and form a mass or tumor, which can spread to other parts of the body, including the bones, liver, and skin. As neuroblastoma advances, it may cause symptoms such as abdominal pain, a lump in the abdomen, or bone pain. The progression can vary significantly, with some tumors growing slowly and others rapidly. The disease can also cause a range of other symptoms depending on the location and size of the tumor.

Trial ID:

2024-513843-10-00

Protocol code:

PS21GAP

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety of 68Ga-SATO and Iodine (123I) Iobenguane in Children with Neuroblastoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?